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MedNess: bite-size biopharma and medtech news

5th January 2021
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MedNess This Week
HIGHLIGHTS
Onco-I-Analyse
BMS’ Opdivo failed interim assessment to show OS benefit in GBM study
On 23rd December, BMS announced that nivolumab (Opdivo), in combination with Temozolomide and RT, will fail to meet primary endpoint of OS in the phase III CheckMate -548 study of newly diagnosed GBM patients.
GBM is an extremely aggressive CNS tumor with very poor prognosis and limited treatment options in more than a decade. The 5-year survival rate in less than 5%. In September 2019, the trial had failed to meet the primary endpoint of PFS in all randomized patients. At that time, DMC recommended to continue to trial as planned for mature OS data.
The announcement came in the wake of a routine review of the trial by an independent data monitoring committee (DMC). The committee notified that based on the number of events reported so far, the study is unlikely to meet its primary endpoint of overall survival in patients with no baseline corticosteroid use or in the overall randomized population. The committee also mentioned that the decision was not based on any safety concerns in the experimental arm.
CheckMate-548 evaluated nivolumab in combination with standard of care (temozolomide + radiation) therapy compared to the SoC. The study involved newly diagnosed GBM patients, following surgical resection, with O6-methylguanine DNA Methyltransferase (MGMT) promoter methylation.
As a result, BMS will now unblind patients' treatment assignments and patients will be counselled regarding the best available treatment options. Patients who derived clinical benefit from Opdivo, can continue treatment with Opdivo based on physician recommendation.
The company will continue full evaluation of the study data and share final results in the future. BMS has also initiated a Phase 2/3 trial of nivolumab + ipilimumab and RT in newly diagnosed, MGMT unmethylated GBM.
Additionally, on 29th December Opdivo failed to show clinical benefit in confirmatory trials for SCLC. In 2018, Opdivo was granted accelerated approval for SCLC. Subsequently, BMS will withdraw this indication from the US market.
Collated by : Shilpa Rawal, PhD
Drug Approvals
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “These three approvals allow patients in Japan to be treated with Lynparza, a targeted treatment personalised to their specific biomarkers. They further underline the critical importance of biomarker testing at diagnosis, which helps physicians determine a course of treatment tailored to individual patients to substantially delay disease progression.”
Tagrisso approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Roy S. Herbst, MD, PhD, chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the ADAURA Phase III trial, said: “Adjuvant Tagrisso has demonstrated an unprecedented disease-free survival benefit for early-stage lung cancer patients with EGFR mutations who face high rates of recurrence even after successful surgery and subsequent chemotherapy. This approval reinforces how critical it is to test all lung cancer patients for EGFR mutations before deciding how to treat them and regardless of their stage at diagnosis. This will help ensure as many patients as possible can benefit from this potentially practice-changing treatment.”
Click here for more Drug Approvals
Regulatory News
Statement on Opdivo (nivolumab) Small Cell Lung Cancer U.S. Indication; indication to be withdrawn from USA market
“We believe in the power of science to address some of the most challenging diseases of our time, and so we pursue innovations with the goal of transforming patients’ lives,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Although we are disappointed by the withdrawal, we appreciate that the FDA shared our commitment to bringing an innovative new therapy to patients with high unmet need when the science pointed in that direction. Similarly, we respect the FDA’s efforts to evaluate accelerated approvals across the industry to ensure the integrity of this important program.”
FDA Grants Priority Review to sBLA for KEYTRUDA® + Chemotherapy as 1L Treatment for Locally Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction Cancer
“Patients with newly diagnosed esophageal and GEJ cancer face an aggressive disease with a poor prognosis, despite the currently available treatment options,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “We look forward to working with the FDA to bring a new option to patients in the first-line setting.”
Click here for more Regulatory News
Trial Results
Final results announced from Ph 2a COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide in 2L Metastatic Pancreatic Cancer (PDAC)
"These results are highly encouraging in light of the extremely challenging population, even among PDAC patients, in this study cohort," said Manuel Hidalgo, MD, PhD, Chief of the Division of Hematology and Medical Oncology and a Senior Member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, and principal investigator of this study. "All patients were initially diagnosed at stage IV, and greater than 70% had liver metastases, key contributing factors to very poor prognoses. I believe the results from this study strongly support further development."
FAILED TRIAL: CANTATA Study of Telaglenastat in RCC Did Not Achieve Primary Endpoint
“We are disappointed that the CANTATA trial did not achieve its primary endpoint, particularly on behalf of the people living with advanced RCC, many of whom could benefit from additional treatment options with novel mechanisms of action to address this difficult-to-treat disease,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “Based on the strong scientific rationale for telaglenastat in KEAP1/NRF2 mutant non-small cell lung cancer patients, and the safety profile observed in CANTATA, we remain dedicated to advancing our randomized KEAPSAKE trial.”
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Trial/Program Status
Ph 2 Registration-Directed Trial of VS-6766 and Defactinib Initiated in Previously Treated KRAS Mutant NSCLC
“Currently available options for patients with KRAS mutant NSCLC are associated with minimal efficacy, as well as resistance and toxicity issues. Our study will further elucidate the impact of VS-6766, alone or in combination with defactinib, in overcoming these challenges to improve outcomes,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “Our VS-6766 and defactinib NSCLC development program’s specific focus on G12V mutations is unique and represents a potentially significant step forward in understanding how we can deliver a better treatment option for these patients.”
Enrollment completed in the TRYbeCA-1 Ph 3 trial in 2L pancreatic cancer patients
“We are extremely pleased that the TRYbeCA-1 trial enrollment has continued to progress on schedule despite the challenges caused by the COVID-19 global pandemic,” said Dr. Iman El Hariry, Chief Medical Officer of ERYTECH. “This achievement is only possible because of the hard work of the study investigators, hospital staff at the trial sites, patients and their families. We look forward to the outcome of the planned interim analysis for superiority early next year.”
Click here for more Trial Status
Collated by : Richa Tewari, PhD
Medness Reviews

A recent study demonstrates how the human brain regulates navigation in a social context
Scientists from the University of California Los Angeles published their findings in a Nature journal, stating that the human brain creates a similar pattern of brain waves while surrounded by other people. Nobel prize-winning study already provided the basic idea that place and grid cells within the temporal lobe controls navigation in rodents. The technical difficulty to study this phenomenon in a human model was the experimental setup, which had to be stable. It essentially needed the electrode implanted human subjects placed under bulky scanners. With a breakthrough innovation, Dr. Nanthia Suthana’s lab came up with the perfect backpack which replaces the scanner. This backpack is wirelessly connected with the implanted electrodes and simultaneously can record brain generated waves. Interestingly, they could find a specific patterned response when subjects were approaching boundaries in a specific room. The result also indicated similar patterns of theta activity when the subject approaches another individual in a room. "Our results support the idea that, under certain mental states, this pattern of brain waves may help us recognize boundaries. In this case, it was when people were focused on a goal and hunting for something."- Dr. Stangl commented, who is the first author of this publication. This groundbreaking neuroscience research opens a new avenue to study how the human brain navigates under more complex scenarios.    
Collated by : Rinki Saha 
Medness Business
Onco-News
A2 Biotherapeutics enters into collaboration agreement with Merck to develop allogeneic cell therapy for solid tumor cancers
“In vitro studies have provided compelling evidence supporting the view that Tmod-based cell therapy can distinguish tumor cells from normal cells, across multiple tumor targets,” said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. “We hope that the combined efforts of Merck Research Laboratories and A2 Biotherapeutics will enable the application of this ingenious approach to improve the treatment of patients suffering from refractory solid tumors.”
Janux Therapeutics Announces Collaboration with Merck to Develop Novel IO Drug Candidates using T-Cell Engager (TRACTr) Technology
“At Janux, we have developed a technology to engineer best-in-class T cell engagers that are potent and highly tumor specific, which is essential for an immune response that kills tumor cells but spares healthy tissue,” said David Campbell, Ph.D., President and CEO of Janux Therapeutics. “Partnering with Merck, a world leader in immuno-oncology, provides us with important expertise and resources in developing next generation T cell engager therapies that will make immunotherapy work for more cancer patients.”
Click here for more on mergers, acquisitions and business news
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Shilpa Rawal, PhD
Onco I-Analyse
Debarati Banik
HealthIT
Rinki Saha
BioPharma News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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