onco_new_pubblication_mozart

We are excited to announce the publication of our latest research, 

"Next-generation sequencing-based evaluation of the actionable landscape of genomic alterations in solid tumors: the 'MOZART' prospective observational study,"

. The study highlights the clinical value of molecular profiling in metastatic solid tumors using comprehensive NGS-based panels to improve treatment algorithms in situations of uncertainty and facilitate clinical trial recruitment.

For more details, the full study is available 

Oncologica new publication: “MOZART” prospective observational study on genomic alterations in solid tumors

new-hope-against-battle-with-cancer

For international travellers, taking their PCR test swab is only the beginning of the Coronavirus PCR test journey. 

In a meeting with Robert Courts MP, Minister for Aviation, Maritime & Security, Oncologica® explained the genetic science and logistics applied daily to thousands of PCR test swabs to determine positive or negative results.

Furthermore, the genomic sequencing of travellers’ positive PCR test results is vital for identifying high-risk COVID-19 variants of concern, to alert NHS Test and Trace and help prevent high-risk virus variants from entering the UK population across our borders.

To help guide the Minister through the PCR swab test journey, Oncologica® presented a video specially created to outline the keys stages of genomic testing and the impact this data driven approach is having on identifying and curbing high-risk variant transmission via incoming international travellers.

YouTube video player

Step 1: The Coronafocus Covid-19 PCR Test Self-Swab Kit

A lot of work happens before PCR swab tests arrive for processing at Oncologica®’s specialist genomic testing laboratory. Travellers across the world first order PCR test kits online at 

 helps link travellers to government travel testing rules and details when kits are dispatched to coincide with PCR test date requirements. Coronafocus self-swab PCR test kits can be used for Pretravel-Fit to Fly, Day 2 Green list country and Day 2 Day 8 Amber list country arrivals and for Day 5 Amber list Test to Release certificates.

The COVID19 PCR test kits are dispatched by courier to customers and each kit includes a packaged self-sample swab, liquid tube with a unique barcode, sealable bag, swab instructions and a prepaid Royal Mail tracked return envelope(s). Travellers receive instructions electronically when placing their orders, explaining how to register and activate their PCR travel test kit by inputting the date and the time the swab was taken into the online customer dashboard prior to return of their kits to the lab for analysis.

Travellers can drop the PCR tests in the tracked return envelopes into Royal Mail priority post boxes located in every town or village , return the PCR sample(s) by hand to the 24/7 Oncologica® lab or contract their own private courier.

When a swab is returned to Oncologica®, scientists prepare the samples for COVID-19 PCR testing. They log the swab into the system with the unique sample number which tracks the PCR swab sample through the process and ensures that names are not directly on display.

The scientists prepare the samples for the Polymerase Chain Reaction (PCR). This checks whether the virus’s genetic information is present in the sample. The swab gets placed in a chemical solution that breaks apart and releases nucleic acids — the RNA whose unique sequences help identify the presence of the virus in a sample.

Coronavirus is a single-stranded RNA virus and needs to be converted into DNA using specific enzymes to enable the PCR process.

The PCR testing technique copies the genetic information and flags any matches with viral sequences.

We are all familiar with the DNA double helix. Each strand is made up of building blocks called nucleotides. PCR breaks these apart, into single strands in the solution. Then, strands of DNA that are custom-built to match the virus’s unique genetic sequences are introduced. If there is viral DNA in the sample, these primer strands will naturally latch onto the complementary strands. In this way, each strand of matching viral DNA gets doubled. The series of events keeps repeating to increase the amount of viral DNA, so that even tiny amounts of virus in the swab sample create copies.

When DNA primers bind with viral strands in the sample, they activate fluorescent signals that help track these genetic matches. In duplicating the viral DNA, every new strand of DNA creates a little light. The PCR doubles the strands in every cycle for exponential growth and light creation. The light cannot be seen by the human eye and is read by the PCR instrument. If a sample includes the virus, then the DNA primer strands bind, and lights accumulate to a level that signifies a positive test.

Oncologica® have capacity to process up-to 40,000 PCR test swabs daily.  COVID-19 PCR swab test results are very specific and sensitive and are accessed via the online customer dashboard usually within 24 hours from booking the swab sample into the laboratory. This is to ensure individuals follow government guidelines to protect their health and prevent virus transmission to families and the wider public.

The UK’s Test and Sequence strategy requires any positive PCR test samples to be sequenced in government-accredited labs. Oncologica® is a leader in COVID-19 PCR testing and sequencing.

Our highly trained scientific and medical team use state of the art high-volume PCR and sequencing instrumentation to support the demands of the international travel testing programme.

The Integrated PCR testing and genomic sequencing strategy is pivotal in identifying emerging high-risk variants on a global scale. These variants can cross our borders rapidly, so sequencing them effectively detects and alerts NHS Test and Trace to emerging strains to help prevent them becoming prevalent in the population.  Sequencing is also important in monitoring vaccine efficacy, informing new vaccines designs and for protection from future escalating outbreaks.

Oncologica® PCR test options are detailed 

Oncologica® video follows COVID-19 PCR swab through genomic lab test

oncologica-new-paper-brain-cancer-biomarkers-v2

Glioblastoma, the most aggressive form of brain cancer is commonly treated with surgery, radiation, and chemotherapy. However, a newly published study from the research team at Oncologica the world-leading genetic cancer testing laboratory based in Cambridge UK, explains how their genetic sequencing research into predictive glioblastoma biomarkers can empower patients and doctors with DNA blueprints to make better targeted therapy decisions. This could lead to improved treatment outcomes beyond the current survival rate of 7% within five years of diagnosis.

The latest anti-cancer targeted therapies and immunotherapies are directed at the genetic DNA mutations that underlie the development and progression of brain cancer. The latest targeted cancer medicines offer great advantages over standard therapeutic approaches as they directly attack the cancer cells but leave normal cells relatively undisturbed. These new genomic targeted drugs have greater specificity and reduce toxic effects for patients compared to conventional chemotherapy.

The fast implementation of these targeted therapies into routine clinical practice has been constrained by a lack of comprehensive genetic screening for these DNA mutations at diagnosis. Furthermore, the processing of tissue biopsies using formaldehyde and wax embedding for diagnosis, results in fragmentation of the DNA test which makes analysis for mutations a challenge.

In Oncologica’s newly published study Oncologica shows how semiconductor biomarker sequencing can be used to accurately screen the fragmented DNA and RNA from routine glioblastoma biopsy/resection samples. This enables comprehensive DNA profiling to be undertaken in the routine initial diagnostic workflow to link detected mutations to a broad range of potential genomic targeted therapies and immunotherapies, rather than wait to see if standard treatments fail to control the disease.

“We are continually researching new ways to improve the genetic test options at initial diagnosis to provide valuable personalised data to aid targeted cancer treatments” said Dr Marco Loddo, Co-Founder and Scientific Director of Oncologica.

“We hope our data will help inform oncologists about the broad range of potential therapies that are now available and that this will translate into improved clinical outcomes for glioblastoma patients in the future said Professor Gareth Williams, Co-Founder and Medical Director at Oncologica.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0245817

Learn more about our Oncofocus genetic test for all solid tumour types

 https://oncologica.com/cancer-tests/oncofocus/

Oncologica new research on detection of brain cancer biomarkers by genomic sequencing to improve survival rates

cross-border-travel

With many people ditching staycations for trips overseas, the risk of traveller related introduction of high-risk COVID19 variants into the UK is a major issue surrounding European and international holiday travel. The UK government day 2 and day 8 covid international testing programme to mitigate this risk is one of the most stringent travel testing initiatives globally. PCR testing and genomic sequencing for UK arrivals coupled with successful vaccine rollout is proving key to safe overseas travel.

In a landmark paper investigating cross border COVID transmission, published online in EClinical Medicine by the The Lancet publication, Prof Williams and Dr Loddo of Oncologica® show data indicating that although vaccines are having a big impact, there is still a high prevalence of high risk SARS-CoV-2 variants entering the UK which could potentially undermine the vaccination programme gains.

The Oncologica® genomic laboratory uses very sensitive PCR testing techniques coupled with fast semiconductor sequencing technology, which enables the precise identification of variants of concern. In this study relating to 203,065 passengers’ tests, around 2 in every 100 travellers were found to have infection involving a broad range of COVID variants. The low sensitivity of pre-embarkation lateral flow testing may contribute to the high prevalence observed in travellers.

The UK government’s day 2 day 8 stringent PCR travel testing programme highlights the importance of monitoring cross border transmission, and the crucial role it is playing in protecting the integrity of the UK national vaccine programme against the import of high-risk variants with immunity evading properties.

The adoption of similar PCR COVID testing strategies in many countries is gaining importance globally as the numbers of new cases of SARS-CoV-2 has nearly doubled over the last 2 months. Therefore, the chances for the emergence of new high risk COVID-19 variants is potentially high.

The study also shows that two doses of the vaccine are highly effective at reducing asymptomatic infection. However, a significant proportion of fully immunized travellers harboured active COVID SARS-CoV-2 infection and there was no difference in the amount of virus particles, referred to as viral load, when comparing vaccinated versus non-vaccinated individuals.

The data indicates that vaccine passports or immunity certificates alone may not be adequate, and need to be supported by Covid PCR testing and sequencing.  Interestingly the measurable amount of virus of the Delta variant was found in the Oncologica® study to be 21-fold higher compared to the Kent variant and this supports the higher transmissibility of this variant now the most dominant in the UK.

Combining rigorous travel PCR testing and sequencing together with vaccination is likely to provide the best opportunity for safe international travel vital for the economy and leisure travel.  Such public health COVID detection measures combined with national NHS track and trace will enable normal activities to resume until the goal of global vaccination is achieved.

COVID vaccination, PCR testing and variant sequencing: The key to safe cross-border travel

test-and-sequence-strategy

Genomic sequencing is yielding critical insights into how the SARS-CoV-2 virus mutates, which variants are the most infectious and how it travels from place to place. Yet sequencing is still rare in most countries, and more than a year since the virus made its deadly debut much about it remains a mystery.

Great Britain has emerged as an international leader in  deciphering the coronavirus’s genetic code: as of the end of December, British scientists had sequenced 7.4% of the country’s COVID-19 positive samples vs. the U.S.’s 0.3%.

A new government regulation is accelerating the pace of genomic research into the virus and cementing the U.K.’s leadership position in the field. As of February 15, all international travellers to Great Britain from  “red list” countries are required to quarantine for 10 days and undergo a polymerase chain reaction (PCR) test, the gold standard for coronavirus detection, on days 2 and day 8. If the traveller tests positive, the sample must be sent to a government-approved lab for genomic sequencing. The rule was prompted by fears regarding coronavirus variants that might prove resistant to vaccines. The B.1.1.7  (Kent) variant, which was first identified in the U.K., does not appear to be vaccine resistant.

To find out more about the U.K.’s sequencing work, ThermoFisher spoke with Dr. Marco Loddo, PhD, and Prof. Gareth Williams, MBChB, PhD, co-founders of Oncologica®, the first government-approved provider of COVID-19 PCR testing and genomic sequencing laboratory services.

The pair discussed the company’s COVID-19 testing and SARS-CoV-2 sequencing work to control the spread of the coronavirus.

Q: Oncologica®, is a precision oncology services laboratory, focusing on molecular profiling of cancer patients to enable targeted therapies. How did you get into the COVID-19 testing space?

Dr. Loddo: It has been an interesting transition for us. We founded our company in 2014 with a focus on  genomic sequencing to identify patients more likely to respond to certain targeted cancer therapies. When the pandemic began, our initial involvement with COVID testing was to offer it to vulnerable, immunocompromised cancer patients. Subsequently, we were invited by the British government to take part in its national testing program. Our  testing has expanded over the past year, and now we’re testing for private companies, educational institutions and others. More recently, we’ve become one of the companies testing international travellers.

The government’s test-and-sequence program is probably the strongest strategy for protecting the borders from new variants of concern.

Q: Has the TaqPath test been your main tool for COVID testing?

Dr. Loddo: We have been using the TaqPath COVID-19 CE-IVD RT-PCR Kit exclusively. TaqPath’s huge advantage is that it’s a multiplex assay — which means that it targets multiple areas of the SARS-CoV-2 genome, enabling it to detect the presence of the virus even when it’s a mutated version. We’ve found that other company’s tests can struggle, particularly if they’re single- or double-target assays, to pick up some of the new variants. With the TaqPath kit, we’re able to identify all the variants. In fact, part of the new government regulations is that single target RT-PCR tests are no longer allowed for international arrivals; labs must now use a multiplex test that targets at least two genes.

Q: For sequencing under the new travel regulations,* you have been validating the 

Dr. Loddo: In genomic sequencing, there are two parameters, “coverage” and “depth,” which determine the accuracy of the sequencing. The coverage we can achieve with AmpliSeq, compared to other sequencing technologies, gives us more accurate data that we can use to more precisely identify new variants, which was very important to us. On a side note, the minimum coverage requirements set by the government are quite low—50%—while Ampliseq covers more than 99% of the SARS-CoV-2 genome, including all serotypes. It’s really important to quickly link information about new variants to the test and trace program.

Dr. Loddo: It has been an interesting transition for us. We founded our company in 2014 with a focus on  genomic sequencing to identify patients more likely to respond to certain targeted cancer therapies. When the pandemic began, our initial involvement with COVID testing was to offer it to vulnerable, immunocompromised cancer patients. Subsequently, we were invited by the British government to take part in its national testing program. Our  testing has expanded over the past year, and now we’re testing for private companies, educational institutions and others. More recently, we’ve become one of the companies testing international travellers.

Q: For sequencing under the new travel regulations,* you have been validating the Ion AmpliSeq SARS-CoV-2 Research Panel. Why did you choose it for this work?

Q: Do you anticipate you’ll be testing a lot of samples through the international arrivals program?

Dr. Loddo: Our capacity is 40,000 tests per day. We had consistent volume of between 15,000-17,000 tests per day until lockdown caused a drop in testing. With new requirements, we expect an extremely high volume of samples from international arrivals, so we are ready to fill up our capacity  for this program. Scaling testing will involve infrastructure expansion and automation, which will enable us to process 40,000 tests per day.

Q: What is the current state of knowledge about the coronavirus variants in the U.K.?

Dr. Loddo: As you know, we had the emergence of the B.1.1.7 (Kent) variant which spread very rapidly. It’s now the most prevalent strain in our country. We even picked up the new B.1.1.7 (Kent) cluster with the E484K mutation, a mutation in the spike protein. This is a variant of concern because, particularly when coupled with the 501Y mutation, it is associated with antigenic change and vaccine bypass.

When the B.1.1.7 (Kent) variant was first characterized in 2020, it had around 26 mutations. Now we’re picking up between 31 and 36 mutations, so the virus is continually changing. It’s so important to pick up these small mutations, which can make a big difference in terms of antigenic change. These changes in the antigens, the virus’s surface proteins, are concerning because a vaccine may no longer recognize the antigens once they’ve changed, and it’s that recognition of the antigens that triggers the immune response to fight off the virus.

Testing and sequencing must be a global endeavour. That’s the only way we can protect our communities from variants traveling around the world.

Q: Once large numbers of people are vaccinated against the coronavirus, is there still a role for genomic sequencing?

Prof. Williams: As more people are immunized, the selective pressure driving these emerging variants will increase. Natural selection will determine which strains become prevalent in the population, as mutations that increase the virus’s transmissibility or ability to evade immune response are most likely to persist. That’s why sequencing is needed to track these strains as they emerge. And again, it’s really important to have full sequencing coverage because the mutational clusters are distributed along the whole of the coding sequence.

Q: What does the future hold for testing and genomic sequencing as a pandemic containment strategy?

Dr. Loddo: This pandemic has really put testing and sequencing on the map, highlighting the importance of both. We have learned how the variants can come across borders very rapidly, often undetected with asymptomatic individuals. I think testing and sequencing are definitely going to be a part of protecting ourselves from future pandemics— being able to identify not just the pathogen and its variants but also the individuals most at risk using immune analysis.

Over the coming year, NGS will play a critical role in enabling immune repertoire profiling to determine vaccine response, assess vaccine efficacy and guide the development of more effective, targeted vaccines. Already, clinical researchers are using NGS to better understand immune response to vaccines and efforts are underway to create a repository for COVID-19 patients’ immune repertoires to advance global research and vaccine discovery efforts.

The U.K.’s genomic sequencing requirement began March 1, see interview on ThermoFisher Behind the Bench

The TaqPath COVID-19 CE-IVD RT-PCR kit is labeled “For In vitro Diagnostic Use”.

The Ion AmpliSeq SARS-CoV-2 Research Panel is labeled “For Research Use Only. Not for use in diagnostic procedures.”

https://www.thermofisher.com/covid19mutations

UK Test and Sequence Strategy Aims to Block Emerging COVID-19 Strains

oncologica-rapid-identification-of-variants

The emergence of Covid-19 variants are a potential threat to the successful global vaccination programmes. Like all viruses, SARS-CoV-2 evolves over time through the acquisition of random mutations in its genome which is an innate characteristic of viral replication. Mutations have the potential to increase the virulence of the virus by for example increasing the transmissibility and/or the severity of the disease.

Of more concern is for the variant to evade the protective immunity generated by previous infection or by vaccination. At least three designated “variants of concern” have been reported including B.1.1.7 (Kent) which was first identified in the UK and drove a surge in cases, B.1.351 (South Africa), which was first identified in South Africa, and P.1 (Brazil), which was first identified in travellers from Brazil who were tested at a Japanese airport.

This threat is being mitigated though Covid-19 sequencing for people who test Covid-19 positive following PCR/antigen swab testing.

Rapid sequencing of swab positive cases enables immediate mobilization of NHS Track and Trace services to prevent the spread of high risk variants in the community.

Test and sequence has been introduced for international travellers arriving in the UK. All international arrivals must undertake PCR Covid-19 testing and quarantine for 10 days. The PCR test is required on or before day 2 and on or after day 8 of their quarantine period. For variant surveillance Covid-19 sequencing is required for cases testing positive.

Testing and sequencing needs to be completed in a short time window (72hours) so that the information can be effectively actioned, namely identifying and isolating individuals carrying high risk Covid-19 variants. To achieve this rapid reporting time Oncologica® has established Coronofocus (

 ), an integrated Test and Sequence platform to combine high capacity PCR testing with SARS-CoV-2 variant identification. Notably Oncologica® utilises semiconductor sequencing technology that enables >99% coverage of the viral coding sequence enabling the precise identification of Covid-19 variants.

Coronafocus provides an effective solution to rapid test and sequence demands and is helping contribute to the UK surveillance programme which is preventing the spread of variants that can potentially circumvent vaccine immunity.

https://www.gov.uk/government/publications/covid-19-surveillance

 Oncologica®’s Coronafocus COVID-19 Test and Sequence platform enables rapid identification of variants of concern

detection-of-biomarkers-in-glioblastoma

Glioblastoma is the most aggressive form of brain cancer, with debilitating symptoms including seizures, memory loss, difficulties in language processing, muscle weakness and visual changes. The standard treatment for glioblastoma involves a combination of surgery, radiation and chemotherapy but have limited impact on survival with the five year survival rate being around 7%.

The exponential increase in modern anti-cancer agents called targeted therapies and immunotherapies are directed at the genetic DNA mutations that underlie the development and progression of cancer. Targeted agents therefore offer the great advantage that they directly attack the cancer cells but leave normal cell relatively undisturbed. Targeted agents therefore show increased specificity and reduced toxicity when compared with conventional chemotherapy.

One of the hurdles to the implementation of targeted therapies into routine clinical practice has been lack of comprehensive genetic screening for these therapy linked DNA mutations at diagnosis. The processing of the tissue biopsies using formaldehyde and wax embedding for diagnosis results in fragmentation of the DNA which makes analysis for mutations a challenge.

In our recent study we show that semiconductor sequencing can be used to robustly screen the fragmented DNA and RNA from routine glioblastoma biopsy/resection samples. This enables comprehensive DNA profiling to be undertaken as part of the routine diagnostic workflow allowing linkage of detected mutations to a broad range of potential targeted therapies and immunotherapies that can be considered should standard treatment protocols fail to control the disease.

https://www.biorxiv.org/content/10.1101/2021.01.11.426191v1

Utilisation of semiconductor sequencing for the detection of predictive biomarkers in glioblastoma

high-capacity-pcr-testing

The Covid-19 pandemic has had major impact on the social and economic activities of the United Kingdom and has resulted in many deaths. The two major initiatives to address the pandemic has been the establishment of high capacity Covid-19 testing coupled to track and trace and the development of vaccines. Oncologica® has contributed to the pandemic by establishing an integrated Covid-19 test and sequencing platform that is being used to control the spread of the disease across the community and also assess the impact of the vaccines in relation to the different Covid-19 variants.

During the early stage of the pandemic Oncologica® initiated Covid-19 PCR/antigen testing for the protection of vulnerable immunocompromised cancer patients. Since May 2020 Oncologica® has contributed to the national testing efforts as part of the volunteer Covid-19 Testing Network to support the DHSC Covid-19 National Testing Programme covering care homes, local authorities, schools and symptomatic testing across test sites.

Oncologica® has now extended its testing more broadly to support businesses, offices, factories, educational institutions, healthcare and transport (aviation, shipping and railway networks).

To date we have undertaken over 600,000 Covid-19 tests. Our contribution to the UK national efforts to address the Covid-19 pandemic was recently recognised by our shortlisting, as part of the Covid-19 Testing Network [CTN], for the Special Covid-19 UK Response Project Award 

https://www.pmi.org.uk/awards2020-special-COVID-19-award

Oncologica® has been listed as an approved government provider for general testing and for the test to release scheme. Following the latest Government requirements for international arrivals Oncologica® now provides genomic sequencing of positive cases in compliance with the new guidelines.

To facilitate the release of lockdown, to aid economic recovery and to enable people to travel we have now increased Covid-19 testing capacity to 40,000 tests/day and optimised our testing workflow to provide the rapid reporting of results with a 12 hour turnaround time.

Oncologica® launches an integrated Test and Sequence platform to combine high capacity PCR testing with SARS-CoV-2 variant identification

harnessing-our-own-immune-system

Immunotherapy, in which the body’s own immune system is harnessed to kill cancer cells in patients with advanced disease, is proving a powerful treatment in around 15% of cancer patients. Importantly this type of treatment can be used to treat a broad range of different tumour types including lung, breast and bladder cancers and melanoma.

The patients who are likely to respond to such treatment can be identified by analyzing the tumour biopsy with a special stain called the PD-L1 test. Tests which are able to identify a patient likely to respond to a particular treatment are called companion diagnostic CDx assays. Oncologica®, in collaboration with AstraZeneca, has recently completed a study involving the participation of internationally recognised pathologists to assess the performance of one of these tests, called the VENTANA PD-L1 (SP263) Assay in lung cancer.

Preliminary findings were presented at the ESMO 2018 congress in Munich, Germany. The study has now been completed and the findings recently published in the Journal of Thoracic Oncology, a leading journal in the field of lung cancer. We have shown that assessment of tumour cell (TC) scores by expert pathologists is highly reproducible in lung tumour samples using the VENTANA PD-L1 (SP263) Assay, thus building confidence in the performance of this test as a companion diagnostic for anti-PD-L1 immunotherapy.

This will help ensure that patients who may benefit from immunotherapy are correctly identified.

Immunotherapy: an anti-cancer treatment based on harnessing our own immune system to attack cancer cells

hope-for-men-with-prostate-cancer

A major trial of an immunotherapy drug has shown it can be effective in some men with advanced prostate cancer.

The men had stopped responding to the main treatment options.

Researchers found that a small proportion of men, described as “super responders”, remained well even after the trial ended, despite a very poor prognosis before treatment.

Last week it was reported the same drug had 

proved effective in treating advanced head and neck cancers

Immunotherapy uses our own immune systems to recognise and attack cancer cells.

It’s already being used as a standard treatment for some cancers such as melanomas – and being tested on many others too.

It found that one in 20 men with advanced prostate cancer responded to the drug pembrolizumab – and saw their tumours actually shrink or disappear altogether.

Although a relatively small number, some of them gained years of extra life, the study in the Journal of Clinical Oncology found.

A further 19% saw some evidence of improvement.

But most patients in the study lived for an average of eight months on the drug.

The phase II clinical trial, led by the Institute of Cancer Research and the Royal Marsden, involved 258 men with advanced prostate cancer who had run out of all other options on treatment.

The most dramatic responses were seen in patients whose tumours had mutations in genes involved in repairing DNA.

Researchers are now investigating whether this group might benefit the most from immunotherapy in a larger trial.

But first, a test to pick out who will respond best is needed, so that doctors know which patients to give it to.

It’s the most common cancer in men in the UK, with 

around 47,700 diagnosed in the UK each year

The number of people diagnosed has been rising over the last 10 years.

This is probably because the population is getting older and more people are having PSA tests.

Around 30% of men with advanced or stage 4 prostate cancer survive their cancer for five years or more after diagnosis.

“Immunotherapy has had tremendous benefits for some cancer patients, and it’s fantastic news that even in prostate cancer, where we don’t see much immune activity, a proportion of men are responding well to treatment,” says Professor Paul Workman, chief executive of The Institute of Cancer Research.

“A limitation with immunotherapy is that there’s no good test to pick out those who are most likely to respond.

“It’s encouraging to see testing for DNA repair mutations may identify some patients who are more likely to respond, and I’m keen to see how the new, larger trial in this group of patients plays out.”

Professor Johann de Bono, a consultant medical oncologist at The Royal Marsden NHS Foundation Trust, was one of those who led the study.

He said: “We don’t see much activity from the immune system in prostate tumours, so many oncologists thought immunotherapy wouldn’t work for this cancer type.

“But our study shows that a small proportion of men with end-stage cancer do respond, and crucially that some of these men do very well indeed.

“We found that men with mutations in DNA repair genes respond especially well to immunotherapy, including two of my own patients who have now been on the drug for more than two years.”

Last week, a separate trial found the same drug kept some people’s advanced head and neck cancers at bay for an average of two years – five times longer than under chemotherapy.

Both studies are part of a growing body of research suggesting immunotherapy could offer hope to an increasing number of cancer patients.

Immunotherapy offers hope for men with prostate cancer

immunotherapy-less-toxic-and-prolongs-life

An immunotherapy drug that could save some cancer patients from the ordeal of extreme chemotherapy may also help them live longer, researchers say.

In a trial, pembrolizumab kept head and neck cancers at bay for an average of two years – five times longer than under chemotherapy. The patients also suffered far fewer side-effects.

Cases of head and neck cancers are rising in the UK and most are diagnosed late, when they are harder to treat.

Derek Kitcherside, 70, from Leicestershire, believes he wouldn’t be here without pembrolizumab.

He was diagnosed with cancer of the voicebox in 2011. When he started coughing up blood three years later, after receiving standard treatment, he was told the cancer had spread to his lungs and was probably incurable.

Derek asked to go on a drug trial and travelled to London every three weeks for two years for treatment with pembrolizumab.

“My tumour was shrinking all the time and I felt a bit better every time I went,” he said. “It made a huge difference to my life.”

Regular scans show the disease is now stable and the tumour is still getting smaller.

“I’m very pleased I can get on with my life,” Derek said.

“I don’t think I’d be here without it.”

It is a treatment that does not kill cancer cells itself but instead stimulates the body’s immune system to attack them. Pembrolizumab is already being used to treat a wide range of advanced cancers, including melanoma – a type of skin cancer that spreads easily.

Experts believe the drug has the potential to treat many more.

Normally, immunotherapy is used after standard treatments like chemotherapy have failed but this trial, in 882 patients from 37 countries, suggests it should be used earlier – and for some people it should be the go-to option.

The drug is given to patients regularly through a drip when their cancer has returned or spread, and is considered incurable.

It is kinder, safer and can keep patients alive for longer, the study in The Lancet found.

In people with advanced head and neck cancer who responded to the drug – one in four – their cancer shrank or stabilised for an average of 23 months.

By comparison, although more patients (36%) responded positively to standard chemotherapy treatment, the improvements lasted on average for only four and a half months.

Those with larger, more aggressive tumours were given the drug in combination with chemotherapy to help slow progress of the disease – which was kept in check for an average of seven months.

The trick is identifying people with tumours that will respond, says Prof Kevin Harrington, oncologist at The Royal Marsden NHS Founation Trust and professor of biological cancer therapies at the Institute of Cancer Research, who led the study,

A test for the presence of immune marker PD-L1 in the tumour means doctors can work this out.

Prof Harrington says approximately 85% of people with advanced or relapsed head and neck cancer would be eligible for pembrolizumab – around 1,300 patients a year.

At the moment, the recommended treatment is a toxic combination of chemotherapy and antibody therapy, which often makes people feel very sick.

The extreme treatment can also cause damage to the kidneys, hands and feet.

Patients given the immunotherapy drug experienced far fewer side-effects.

“It’s more sensible and less toxic – patients live longer and feel better,” says Prof Harrington.

“This study is very exciting”, says Prof Paul Workman, from the Institute of Cancer Research.

“Firstly because it shows that immunotherapy can have dramatic benefits for some patients with head and neck cancer when used as a first-line treatment, and secondly because the researchers have devised a test for picking out who is most likely to benefit.”

He said all new drugs coming on to the market should be accompanied by a test to target their uses as precisely as possible.

In the US and the EU, pembrolizumab has been approved for use on its own and with chemotherapy for advanced head and neck cancer, but not yet in the UK.

The National Institute for Heath Care and Excellence is currently appraising pembrolizumab and it could be approved for use on the NHS by next summer.

Cancer immunotherapy drug “less toxic and prolongs life”

oncofocus-karan-testimony

Karan Jensen was diagnosed in 2017, aged 48 with cervical cancer. Karan ordered the Oncofocus® Test to identify additional treatment options and shares her story here in the following Q&A.

I had been having regular smear tests, but then one came back with irregular cells and the doctor asked to see me in 6 months time. We were moving, so I delayed going back, but when I did get to the doctors, they ended up doing a biopsy. Within 2 weeks I was diagnosed with Stage 2B cervical cancer with lymph node involvement.

Treatment was started to cure my cancer. I had four cycles of chemotherapy plus 32 sessions of radiotherapy.

Unfortunately, the tumour did not change with this type of chemotherapy, so I then started on alternative therapies.

I was meant to have six sessions of this chemotherapy, but after three, I had a scan and found out that the tumour had grown. I was told that there was no point continuing treatment as my cancer was incurable, and to go home and get things in order.

Did you experience any side effects of chemotherapy?

During chemotherapy, I was hospitalised four times with infections and neutropenic sepsis. The chemotherapy also caused swelling of my legs (lymphoedema), and my kidneys had been damaged so that I had to have a nephrostomy bag attached to collect urine.

How did you feel when they told you that you cancer was incurable?

I have an 11-year-old son, so I was not going to give up and did some research online on the best treatments for my cancer.

I found out about the Oncofocus®® cancer test by Oncologica® on their website and got in touch.

Was it easy getting the Oncofocus® test done?

It cost £2000 but it was an easy decision to make. I just had to fill in a few forms and Oncologica® did all the work to get the biopsy from my hospital.

What were the results of the Oncofocus® test?

The test quickly came back that my tumour was exceptionally high in a protein called PD-L1, so it would respond really well to immunotherapy, which works by boosting a person’s immune system to help it recognise and fight cancer cells.

What happened when you knew the results of the test?

The treatment that the test recommended was not available on the NHS so my oncologist contacted Christie Hospital in Manchester, which was part of the PROCLAIM-CX-072 clinical trial that is investigating an experimental drug that targets PD-L1.

I was very sick at this stage, and the doctors were not sure that I would be well enough to get into the trial. As my levels of PD-L1 were so high, however, they thought they had to give me the opportunity.

I was meant to have four sessions of CX-072 plus ipilumumab every 3 weeks, plus CX-072 maintenance therapy for a year. Although the treatment was not as bad as chemotherapy and I did not lose any hair, it still made me feel very poorly. After the third session, I developed a bad reaction and the level of some of my white blood cells that fight infection, neutrophils, plummeted and could not be restored to normal. It was therefore too risky to continue the treatment.

The good news was that a scan in March this year showed that the new therapy had reduced the tumour by 50%.

Even though the treatment has stopped, my immune system has taken over and is fighting the tumour. I am scanned every 2 months, and every time my tumour reduces by a further 0.5% to 1%. Last week I had another scan, and it had reduced by 3% and I feel better today than I have over the past 3 years.

What are your thoughts on the Oncofocus® test?

If I had had the test before receiving chemotherapy, this would have saved the NHS a load of money giving me a treatment that did not work and putting me through so much. I continue to need a nephrostomy bag due to the damage done by chemotherapy, which needs changing once a week and the tubes replaced in hospital every 3 months.

We are now at the ‘watch and wait’ stage. However, as I have had such a good response to the immunotherapy and feel so much better, I can have more treatment if needed in the future. The swelling in my leg has gone down and I can now wear my shoes and move around normally again. I was so sick that I did not think that I would see last Christmas. Now I will get to experience Christmas again this year.

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