On September 21, 2020 AstraZeneca and MSD’s Lynparza (olaparib) reported that has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer (Press release, AstraZeneca, SEP 21, 2020, View Source [SID1234565401]).

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a biomarker subgroup analysis of the PAOLA-1 Phase III trial, which was published in The New England Journal of Medicine.

The trial showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). The addition of Lynparza improved progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.1-3

Ovarian cancer is the fifth most common cause of cancer death in Europe and the five-year survival rate is approximately 45%, due in part because women are often diagnosed with advanced disease (Stage III or IV).4,5

José Baselga, Executive Vice President, Oncology R&D, said: "Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Lynparza together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years, offering new hope for women in this setting. This recommendation is a vital step toward addressing a significant unmet need and could bring a new treatment option that delays relapse in this devastating disease."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "HRD is an important biomarker of advanced ovarian cancer that can inform how physicians in the EU treat this aggressive type of cancer. This recommendation and the results from the PAOLA-1 trial underscore the importance of HRD testing at diagnosis to determine the best course of treatment for women with advanced ovarian cancer."

The CHMP recommendation is for Lynparza in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with HRD positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.

Further results from the PAOLA-1 trial recently presented during the 2020 European Society for Medical Oncology virtual congress showed that Lynparza in combination with bevacizumab maintenance treatment demonstrated a statistically significant improvement in the time to second disease progression (PFS2) versus bevacizumab alone in patients with HRD-positive advanced ovarian cancer, a key secondary endpoint. The results showed Lynparza with bevacizumab provided benefit beyond first disease progression, improving PFS2 to a median of 50.3 months versus 35.3 months with bevacizumab alone.

Lynparza in combination with bevacizumab is approved in the US and several other countries as a 1st-line maintenance treatment for patients with HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries around the world.

Ovarian cancer

In 2018, there were nearly 68,000 new cases of ovarian cancer diagnosed in Europe and around 45,000 deaths.4 Approximately 50% of ovarian cancers are HRD-positive including BRCA1/2 mutation.6,7 Approximately 22% of ovarian cancers have a BRCA1/2 mutation.6-8

Homologous recombination deficiency

HRD, which defines a subgroup of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.9

PAOLA-1

PAOLA-1 is a double-blind Phase III trial testing the efficacy and safety of Lynparza added to standard-of-care bevacizumab versus bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS in the overall trial population.

Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for HRR gene-mutated mCRPC (BRCAm and other HRR gene mutations). Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 30,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On September 21, 2020 Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, reported that promising new data for its investigational advanced adenoma (precursor lesions of colorectal cancer) detection blood test and multi-cancer detection test was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Universal Diagnostics, SEP 21, 2020, View Source [SID1234565395]).

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Despite the fact that more than 80% of colorectal cancers (CRC’s) originate from advanced adenomas (AA), current screening methods are not accurate enough to provide detection early enough to prevent CRC. The data presented at ESMO (Free ESMO Whitepaper) 2020, shows that the evaluation of a panel of cell free DNA (cfDNA) open chromatin regions in plasma can be successfully used for AA detection with high accuracy. These results are further supporting the companies previous findings on using cfDNA derived methylation signals for AA and early colorectal cancer detection.

"Only about a quarter of colorectal cases are caught in the very early, precancerous stages. By screening and detecting molecular changes early, there is a better chance of effectively treating patients or even preventing cancer altogether. Previous research suggests that kinetic analysis and molecular profiling of cfDNA could potentially be used in non-invasive cancer detection and management. The data presented at ESMO (Free ESMO Whitepaper) 2020 supports this proposition, particularly in screening for colorectal adenomas," said Michael H. A. Roehrl, MD, PhD, Director, Precision Pathology Center at Memorial Sloan Ketting Cancer Center and Member of the Scientific Advisory Board of UDX. "We urgently need a population-scale colon cancer screening that is cost-effective and blood based, to encourage higher patient compliance and to detect patients with precancerous lesions. The UDX approach could potentially provide that platform."

In Poster ID 479P titled "Open chromatin region (OCR) based model predicts advanced adenoma in plasma cell-free DNA whole genome bisulfite sequencing data", the researchers validated an OCR panel performance on plasma cfDNA samples. The results show that 50% of AA samples being correctly identified at 90% specificity. The test is able to detected 100% serrated adenoma, 50% tubulovillous adenoma and 25% tubular adenoma patients. More importantly, the detection rate is comparable for patients with high grade dysplasia (50%) and with low grade but >1cm findings (50%). With this abstract UDX confirms the test’s ability to pick up the signal coming from advanced adenomas. The ability to add open chromatin information to its panel could potentially enhance the already strong results presented at ESMO (Free ESMO Whitepaper) GI in July 2020, which showed 62.5% sensitivity and 88% specificity.

A second poster (ID 97P), titled "A panel of methylation markers for multi-cancer detection from plasma", shows performance data of UDX’s blood test in the detection of four cancer types – colorectal (CRC), lung (LC), pancreatic (PaC) and breast (BC) cancer. The methylation marker panel based test is able to detect 100% of the CRC, 80% of the PaC, 75% of the BC and 73% of LC with low false-positive rate at 90% specificity. Importantly, the sensitivity for earlies, stage I cancers is 75%, further solidifying the tests potential. Further on, for cancers detected, the test also identifies where the cancer is located in the body with 80% of CRC, 78% of LC, 75% of PaC and 62% of BC cases correctly assigned to tissue of origin.

"Building on encouraging preliminary data in colorectal cancer and adenomas, the data presented at ESMO (Free ESMO Whitepaper) 2020 suggests that the UDX test may also have an application in the early detection of lung, pancreatic and breast cancers," said Dr. James Kinross, Senior Lecturer in Surgery at Imperial College Healthcare NHS Trust and co-author of the study. "Of course these data need now to be validated in larger prospective cohorts but it does suggest that UDX are developing a highly promising and minimally invasive blood-based cancer screening test to detect and ultimately prevent multiple cancers."

"These data presented at ESMO (Free ESMO Whitepaper) 2020 continue to show that our cfDNA panels have potential for use in the early, blood-based detection of colorectal cancer, our lead indication, but also in other cancers types, all with high sensitivity and specificity," said Juan Martínez-Barea, Co-Founder and President of Universal Diagnostics. "We intend to complete our ongoing verification study by end of 2020 and plan to finalize internal validation of our CRC/AA test by the end of 2021. In parallel, we will expand our cancer diagnostic platform to create more substantial data for other cancers, for example, the most frequently diagnosed cancers such as lung cancer."

About the Colorectal Cancer and Advanced Adenoma Test

UDX’s first product is a simple, non-invasive and accurate blood-based screening test that allows early stage colorectal cancer detection and cancer prevention through advanced adenoma detection. Using profiling of DNA methylation changes in large number of tissue and plasma samples, UDX has identified and quantified a proprietary panel of biomarkers that has been combined into targeted assays that have shown 77% sensitivity for colorectal cancer, 62.5% sensitivity of adenomas and 88-90% specificity and tissue of origin accuracy across different verification studies.

On September 21, 2020 Scenic Biotech BV ("Scenic"), a pioneer in the discovery of genetic modifiers to enable the development of disease modifying therapeutics for rare genetic disorders and other devastating illnesses, reported that it has entered into a multi-year strategic collaboration with Genentech, a member of the Roche Group, to discover, develop and commercialize novel therapeutics that target genetic modifiers (Press release, Scenic Biotech, SEP 21, 2020, View Source [SID1234565394]).

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Genetic modifiers are genes that counteract the effect of a disease-causing gene. They may explain why some people with genetic mutations linked to severe disease end up having only mild or no symptoms. Also known as disease suppressors, genetic modifiers therefore positively influence the severity of disease and act as a ‘natural form of protection’. Their discovery is leading to a completely new class of drug targets.

Under the terms of the agreement, Scenic will utilize its Cell-Seq platform and its data warehouse of genetic modifiers to identify drug targets in multiple therapeutic areas. The collaboration enables Genentech to select multiple targets for further development with an option to extend the collaboration. Scenic will receive an undisclosed upfront payment and is eligible to receive additional target selection fees for drug targets taken forward by Genentech. In addition, Scenic is eligible for success-based payments for each target based on achievement of certain predetermined milestones, as well as royalties on sales of certain products resulting from the collaboration. Total deal value could exceed US $375M.

Scenic has built an extensive proprietary data warehouse of genetic modifiers and its Cell-Seq platform enables the development of potential disease modifying therapeutics for devastating diseases with an in-house focus on inherited rare diseases and immuno-oncology/inflammation.

The Company was founded in 2017 as a spin-out of the Netherlands Cancer Institute, and Oxford University and recently appointed Oscar Izeboud, PhD as its Chief Executive Officer.

Dr Sebastian Nijman, Co-founder and CSO of Scenic Biotech said: "Genentech is the pioneer in innovative biotech and has world leading research and development capabilities. Scenic is a science-driven company and having Genentech as our first major industry partner is a great validation of our technology and by working together it will extend the utility of our platform beyond our current therapeutic areas of interest. The collaboration also brings significant strategic value for Scenic as it enables us to realise the potential of our genetic modifier expertise alongside independently advancing our own programs towards clinical development."

On September 21, 2020 DCprime, the front-runner in the field of relapse vaccines, and Glycotope GmbH, a clinical-stage oncology/immuno-oncology company built on world-leading glycobiology expertise, reported an expansion of their existing partnership through a new research collaboration and licensing agreement (Press release, DCPrime, SEP 21, 2020, View Source [SID1234565389]).

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Originally initiated in July 2018, the partnership combines DCprime’s proprietary DCOne relapse vaccine platform and Glycotope’s highly specific anti-tumor antibody platform with the aim of developing novel immunotherapeutic approaches in oncology. Under the expanded agreement a therapeutic antibody program has been selected from Glycotope’s portfolio which will be further evaluated in preclinical studies to potentially treat a broad range of solid tumors.

"Today’s agreement further exemplifies our commitment to develop novel cancer immunotherapies based on partnerships, in addition to pioneering the relapse vaccine paradigm. Our relationship with Glycotope has matured and brought forward a very promising program, potentially leading to a highly differentiated novel combination therapy towards solid tumors," commented Erik Manting, CEO of DCprime.

"We are delighted to expand our collaboration with DCprime and to see one of our antibody programs move forward in a novel combination therapy approach with a cancer vaccine based on the DCOne platform," said Henner Kollenberg, Managing Director of Glycotope GmbH. "Glycotope has developed a growing pipeline of high-value cancer therapies and today’s announcement further highlights the promising product opportunities for monotherapeutic or combinational approaches offered by our portfolio."

On September 20, 2020 Amgen (NASDAQ: AMGN) reported that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM) (Press release, Amgen, SEP 20, 2020, View Source [SID1234565397]). Data from 59 patients with advanced non-small cell lung cancer reported in the NEJM manuscript were also featured today during an oral presentation at ESMO (Free ESMO Whitepaper) 2020.

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"CodeBreaK 100 is the largest Phase 1/2, and first-in-human, clinical study for a KRASG12C inhibitor," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Earlier this year at ASCO (Free ASCO Whitepaper), we reported encouraging early data in patients with advanced colorectal cancer and a number of other solid tumors. We’re pleased to share these updated Phase 1 results, particularly in patients with advanced non-small cell lung cancer, and look forward to the Phase 2 readout in this heavily pretreated population later this year."

Sotorasib demonstrated confirmed objective response rate (ORR) and disease control rates (DCR) of 35.3% and 91.2%, respectively, in 34 heavily pretreated patients (median of two prior lines of therapy) with NSCLC, who were treated with the 960 mg daily dose (data cutoff of June 1, 2020).

Anticancer activity was seen across all dose levels in patients with NSCLC, with a confirmed ORR of 32.2% and DCR of 88.1%, and median duration of response of 10.9 months, with 10 of 19 responders still in response as of the data cutoff. Tumor shrinkage was observed in 71.2% of patients at the first week-6 assessment. Median progression-free survival (mPFS) in patients treated with sotorasib was 6.3 months.

Safety and tolerability in patients with NSCLC were consistent with previously seen CodeBreaK 100 results. No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). The most common TRAEs were diarrhea (25.4%), alanine aminotransferase (ALT) increase (20.3%), aspartate aminotransferase (AST) increase (20.3%), fatigue (10.2%) and nausea (10.2%). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment.

"These latest results show that sotorasib continues to demonstrate encouraging clinical benefit in heavily pretreated patients with KRAS G12C-mutant tumors," said lead author David S. Hong, M.D., Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, TX. "The results also establish a compelling trend in tumor shrinkage and median progression-free survival with a positive benefit-risk profile."

The ESMO (Free ESMO Whitepaper) oral presentation included Phase 1 NSCLC results published in NEJM, as well as data on potential biomarkers of response to sotorasib that demonstrated clinical activity across a range of KRAS G12C mutant allele frequencies (MAFs), PD-L1 tissues expression levels, tumor mutational burden (TMB) plasma levels and tissue co-mutational profiles.

"KRAS G12C is a driver of multiple solid tumor types and is particularly prevalent in non-small cell lung cancer," said Fabrice Barlesi, M.D., Ph.D., Professor of Medicine at Aix-Marseille University, Medical Director of Gustave Roussy Institute, Paris, France. "Despite this, there are currently no approved targeted therapy options for KRAS G12C and patients remain in need of additional treatment options, which makes these new findings particularly important."

Amgen Webcast Investor Call
Amgen will host two webcast calls for the investment community in conjunction with the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen’s clinical development team, will discuss the Phase 1 data being presented on the Company’s investigational half-life extended bispecific T-cell engager (BiTE) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

About KRAS
The RAS gene family, which has been the subject of almost four decades of research, contains some of the most frequently mutated oncogenes in human cancers.1,2 Targeting the KRAS protein, the most commonly altered family member in solid tumors, has been one of the toughest challenges in cancer research.1 A specific mutation known as KRAS G12C, is a major driver of tumor growth, occurring broadly across solid tumor indications. In the U.S., about 13% of patients with non-small cell lung cancer harbor the KRAS G12C mutation.3,4 It is also found in approximately 3-5% of colorectal cancers and 1-2% of numerous other solid tumors, making this among the most broadly represented mutations across cancer patient subgroups.5,6,7,8,9. With the discovery of a unique surface groove in the KRASG12C protein, Amgen developed and advanced the first investigational KRASG12C inhibitor into the clinic and is exploring the potential of KRASG12C inhibition across multiple tumor types for patients who remain in dire need of treatment options.1,10

About CodeBreaK
The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

Amgen’s single-arm Phase 2 trials in both non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK 100) are now fully enrolled. The potentially registrational Phase 2 trial in NSCLC is on track for data readout later in 2020 and a global Phase 3 randomized active-controlled confirmatory study comparing sotorasib to docetaxel in NSCLC (CodeBreaK 200) has begun recruiting. The Phase 2 CRC trial is expected to have a data readout in 2021. Amgen is also currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101).

Additional information about CodeBreaK clinical trials can be found at View Source

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.