On October 25, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has launched the AVENIO Tumor Tissue CGP Kit (Press release, Hoffmann-La Roche, OCT 25, 2021, View Source [SID1234591878]). The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house. Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer.

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Cancer is a disease of the genome and treatment no longer depends solely on the tissue of origin. Rather, cancer is a collection of dozens or even hundreds of diseases driven in part by specific genomic characteristics.

"To treat cancer effectively, we must understand what drives it at a molecular level. CGP helps inform decisions about available treatment options, including targeted therapies, immunotherapies, tumour-agnostic treatments and clinical trial participation, based on the unique genomic profile of a patient’s tumour," said Thomas Schinecker, CEO of Roche Diagnostics. "We are bringing powerful insights from CGP to enable smarter, more efficient research and development. Our new kit provides the information researchers need and will ultimately provide insights physicians can use to develop personalised treatment strategies for individual patients."

Unlike smaller panels such as hotspot or single gene tests, CGP tests deliver comprehensive information in a single test and can also provide information on complex genomic signatures such as Tumour Mutational Burden (TMB), Microsatellite Instability (MSI) and Loss of Heterozygosity (LOH).

The kit for research use is just the first step in bringing CGP closer to people living with cancer through enabling critical research and clinical trials in laboratories across the world. The kit will launch in regions throughout the world including Europe, North America, Asia and South America. Roche and Foundation Medicine also plan to develop additional solutions for its portfolio.

"The launch of this kit will significantly expand access to genomic profiling globally by providing an in-house solution for those who cannot otherwise access our portfolio of tests through our centralised laboratories," said Foundation Medicine Chief Executive Officer Brian Alexander. "The launch of the kit strengthens our ability to act as an essential partner to researchers in navigating the complex landscape of cancer care."

About the AVENIO Tumor Tissue CGP Kit
The AVENIO Tumor Tissue CGP Kit is a Research Use Only next-generation sequencing test that provides an end-to-end workflow from DNA extraction and library preparation to generation of variant results by the FoundationOne Analysis Platform via AVENIO Connect. The Kit uses a gene panel based on the FoundationOne platform that was designed to match the FoundationOne CDx panel content to analyse 324 cancer-related genes across four main classes of genomic alterations and genomic signatures known to cause and drive cancer. These genes provide valuable insights on biomarkers known today and emerging biomarkers of tomorrow.

Each of the kits is configured for running 24 samples, with the entire workflow from DNA isolation to variant results completed in 5 days. The kit runs on Illumina’s NextSeq 500/550 RUO and NextSeq 550 Dx System in research mode. In January 2020, Roche entered into an agreement with Illumina to develop, manufacture and commercialise AVENIO tests for both tissue and blood for use on Illumina’s IVD systems.

On October 25, 2021 Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, reported that it has entered into a clinical trial collaboration and supply agreement with subsidiaries of Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), to evaluate the combination of Evaxion’s cancer immunotherapy EVX-01 with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a new Phase 2b study (Press release, Evaxion Biotech, OCT 25, 2021, View Source [SID1234591877]).

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The planned multicenter Phase 2b trial will enroll patients with metastatic melanoma stage III and stage IV and will investigate the personalized neoepitope immunotherapy EVX-01 in combination with KEYTRUDA. It is expected to be initiated in Q4 2021. Under terms of the agreement, Evaxion will be responsible for the conduct of the study; MSD will supply all of the necessary KEYTRUDA and will continue to collaborate as the data mature.

Lars Wegner, CEO of Evaxion, said: "We are extremely proud to collaborate with MSD, one of the world’s premier immuno-oncology companies, on our upcoming Phase 2b trial with EVX-01. The promising Phase 1/2a data, which we reported in July, showed that EVX-01 may be able to improve the treatment landscape in melanoma and potentially other cancers. Now that checkpoint inhibitors including KEYTRUDA have become the standard of care for these patients, we are excited about the potential additive benefits of our drug candidate to further improve treatment and to strengthen the evidence supporting our platform and clinical pipeline. Futhermore, this collaboration will also reduce the cost of conducting our Phase 2b trial on EVX-01."

The ongoing Phase 1/2a trial is investigating EVX-01, a novel personalized cancer neoepitope immunotherapy based on Evaxion’s proprietary PIONEER AI technology, for the treatment of patients with melanoma.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Kenilworth, NJ, USA.

On October 25, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported top-line results from its Phase 3 TRYbeCA-1 clinical trial evaluating eryaspase as second-line treatment in 512 patients with metastatic pancreatic cancer (Press release, ERYtech Pharma, OCT 25, 2021, View Source [SID1234591875]). The trial did not meet its primary endpoint of overall survival (OS).

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In the TRYbeCA-1 trial, eryaspase demonstrated an improvement in the primary endpoint of OS compared to chemotherapy alone with a hazard ratio (HR) of 0.92 (95% confidence interval (CI), 0.76-1.11) in the intent-to-treat population, and the difference was not statistically significant (p-value 0.375). The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months (95% CI, 6.5-8.3), compared to 6.7 months (95% CI, 5.4-7.5) for chemotherapy alone.

Interestingly, while the patients treated with gemcitabine plus nabpaclitaxel did not experience a survival benefit from the addition of eryaspase, patients treated with eryaspase and an irinotecan-based chemotherapy regimen showed nominal survival benefit with a HR of 0.77 (95% CI, 5.7-1.05) over those treated with chemotherapy alone. This prespecified subgroup had a median OS of 8.0 months in the eryaspase-treated arm versus 5.7 months in the control arm (per protocol population).

Key secondary endpoints of the trial, including progression-free survival, disease control rate and objective response rate, showed benefit in favor of eryaspase.

The safety profile of eryaspase observed in the TRYbeCA-1 trial was consistent with earlier observations and previous safety reviews by the trial’s independent data monitoring committee (IDMC).

Further analysis of the data will be performed, and full results will be presented at an upcoming medical conference.

ERYTECH will now focus on its late-stage program in acute lymphoblastic leukemia (ALL) and pursue a path to approval in hypersensitive ALL based on positive results of NOPHO-sponsored Phase 2 trial. The Company reiterates its intention to submit a BLA before the end of the year.

"While the results are disappointing, we congratulate the company for a very well managed trial in this difficult disease. With a median survival of 7.5 months, ERYTECH has created a new reference standard for clinical evaluation in second line pancreatic cancer", said Prof. Pascal Hammel, MD, PhD, gastroenterologist-oncologist at Beaujon Hospital in Paris and co-principal investigator of the TRYbeCA-1 trial.

"I agree with Prof Hammel, and want to add that the results in the subgroup of fluoropyrimidine-based treatments are, with a median survival of 8 months, really remarkable and merit further investigation. Especially since this was also the better subgroup in the Phase 2b trial", said Prof. Manuel Hidalgo, M.D., Ph.D., Weill Cornell Medicine/NewYork-Presbyterian Hospital, and co-principal investigator of the study.

"Pancreatic cancer is a very challenging, heterogeneous disease, and the results of the TRYbeCA-1 Phase 3 trial have now also encountered this significant hurdle." said Dr Iman El Hariry, Chief Medical Officer of ERYTECH. "It is very disappointing that the clinical benefit eryaspase demonstrated in the Phase 2 trial was not confirmed; however, the study has addressed important questions in the management of pancreatic cancer patients. I want to thank the patients, their families and healthcare providers, our vendors, as well as our colleagues at ERYTECH, who overcame many obstacles, including the COVID-19 pandemic, to execute this important trial. Targeting the altered asparagine and glutamine metabolism of cancer cells, well established in ALL, remains an important field of development, also for the field of solid tumors. The ERYTECH team along with its clinical advisors will review the full data analyses including the secondary and exploratory endpoints and provide a more detailed update on additional subgroup analysis after these are completed".

"These results are highly disappointing, not only for the ERYTECH team, but also for patients and healthcare providers as there continues to be a major unmet medical need in pancreatic cancer." added Gil Beyen, CEO of ERYTECH. "We continue to believe in the potential of cancer metabolism and our ERYCAPS platform to treat aggressive forms of cancer, and will, while evaluating the potential to continue the development in pancreatic cancer, now continue to focus on seeking approval of eryaspase for ALL patients who developed hypersensitivity to pegylated asparaginase. This is also an important medical need and a potentially attractive market opportunity for eryaspase. We confirm our previously announced intention to submit a BLA for this indication by year-end 2021. We will evaluate our strategic and partnering options in the coming weeks and will provide updated guidance on our global corporate strategy later in the year."

TRYbeCA-1 Top-line Results and Analysis Conference Call Details

ERYTECH management will hold a conference call and webcast on October 25, at 8:30am EDT / 2:30 pm CEST highlights the top-line results and plans for future approval and launch in 2022. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The audio call is accessible via the below registering link: View Source (Conference ID : 2361482). Once registered, participants will receive a unique access code and the call number details to join the teleconference.
The webcast can be followed live online via the link: View Source
An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

An archived replay of the audio call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 2361482#.

On October 25, 2021 Bristol Myers Squibb (NYSE:BMY) reported that it has changed the timing of its previously announced earnings conference call (Press release, Bristol-Myers Squibb, OCT 25, 2021, View Source [SID1234591874]). The Company will now host a conference call to discuss results for the third quarter of 2021 on Wednesday, October 27, 2021 at 10:00 a.m. ET . During the call, company executives will review financial results and address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Investors and the general public can also access the live webcast by dialing in the U.S. toll free 800-263-0877 or international +1 313-209-7315, confirmation code: 8911662. Materials related to the call will be available at the same website prior to the conference call.

A replay of the call will be available on View Source or by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 8911662. The replay will be available beginning at 1:30 p.m. ET on October 27 through 1:30 p.m. ET on November 10, 2021.

On October 25, 2021 AstraZeneca reported that Positive high-level results from the TOPAZ-1 Phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC) (Press release, AstraZeneca, OCT 25, 2021, View Source [SID1234591868]).

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At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an improvement in OS in patients treated with Imfinzi plus chemotherapy versus chemotherapy alone. The combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints.

Imfinzi plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone.

BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.1,2 Incidence of BTC often depends on the prevalence of common risk factors for each type within a geographical region.

Approximately 50,000 people in the US, Europe and Japan and about 210,000 people worldwide are diagnosed with BTC each year.3-5 These patients have a poor prognosis, with approximately only 5% to 15% of all patients with BTC surviving five years.4 In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC.

Do-Youn Oh, MD, PhD, Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University Hospital and Seoul National University College of Medicine, and principal investigator in the TOPAZ-1 Phase III trial, said: "Patients with advanced biliary tract cancer are in dire need of new treatments as progress in the 1st-line setting has remained largely stagnant for more than 10 years. TOPAZ-1 is the first Phase III trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for patients in this setting. Today’s exciting results are a major step forward in treating this disease and represent new hope for our patients."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are delighted TOPAZ-1 has been unblinded early due to clear evidence of efficacy for Imfinzi plus chemotherapy, which has also demonstrated a strong safety profile. We have now delivered two positive gastrointestinal cancer trials in a row for Imfinzi, following the HIMALAYA trial in liver cancer. We believe the significant survival benefit demonstrated marks a new era of immunotherapy treatment in this devastating disease, and it advances our commitment to improving long-term survival for patients across these cancers where treatment options are limited."

The data will be presented at a forthcoming medical meeting and shared with health authorities.

Notes

Biliary tract cancer
Biliary tract cancer (BTC) is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).1,2 Cholangiocarcinoma is more common in China and Thailand and is on the rise in Western countries.8-10 Gallbladder cancer is more common in certain regions of South America, India and Japan.11,12

Apart from ampullary cancer, early-stage BTC often presents without symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited and the prognosis is poor.13,14

TOPAZ-1
TOPAZ-1 is a randomised, double-blind, placebo controlled, multicentre, global Phase III trial of Imfinzi in combination with chemotherapy (gemcitabine plus cisplatin) versus placebo in combination with chemotherapy as a 1st-line treatment in 685 patients with unresectable advanced or metastatic BTC including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer (ampullary carcinoma was excluded).

The trial is being conducted in more than 145 centres across 17 countries including in the US, Europe, South America and several countries in Asia including South Korea, Thailand, Japan, Taiwan and China. The primary endpoint is OS and key secondary endpoints include progression-free survival, objective response rate and safety.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy and is the global standard of care in this setting based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.

Imfinzi is also approved for previously treated patients with advanced bladder cancer in several countries. Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, liver cancer, BTC, oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumours.

AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.15

Within this programme, the Company is committed to improving outcomes in gastric, liver, BTC, oesophageal, pancreatic, and colorectal cancers.

Imfinzi is being assessed in combinations in liver, BTC, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease. In October 2021, the HIMALAYA Phase III trial in 1st-line unresectable liver cancer met its primary endpoint of overall survival with the STRIDE regimen, a single, high priming dose of tremelimumab plus Imfinzi every four weeks versus sorafenib.

The Company aims to understand the potential of Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, in the two most common GI cancers, colorectal and gastric cancers. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy, targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.