More than $170 million was paid out for drugs that manufacturers voluntarily withdrew from the market after subsequent trials showed no benefit in overall survival.
It might only be Wednesday, but the second last week of October has been chock-full of news. From an eye-opening paper on the results of Medicare spending on cancer drugs to clinical endpoints met and missed, and a plethora of news about the COVID-19 virus, it’s difficult to keep up! So allow BioSpace to be your guide.
New Study Adds Fuel to Scrutiny Around FDA’s Accelerated Approval Process
According to analysis published Monday by JAMA Internal Medicine, Medicare spent nearly $600 million to pay for four cancer drugs that were later found to provide no clinical benefit in some indications for which they were approved by the U.S. Food and Drug Administration.
More than $170 million was paid out for drugs for cancers including breast, lung, liver and urinary tract carcinomas that manufacturers voluntarily withdrew from the market after subsequent trials showed no benefit in overall survival.
The analysis, which focused on Medicare Part B and Part D spending between 2017 and 2019, zeroed in on four medications: Genentech (Roche)’s Tecentriq (atezolizumab), AstraZeneca’s IMFINZI (durvalumab), Bristol Myers Squibb’s Opdivo (pembrolizumab) and Merck’s Keytruda.
“We are spending a significant amount of money on these drugs, which do not have proof of efficacy,” stated study co-author Mahnum Shahzad, a doctoral student in health policy at Harvard University. “That is not to say that approving these drugs was a bad idea, but more that the public needs to understand that because a drug is approved, it does not mean we are certain it has benefit.”
The findings pour more fuel on the fire of scrutiny surrounding the agency’s “accelerated approval” program, which aims to deliver new therapies to patients faster by expediting the evaluation process. Perhaps the most notable recent drug to receive approval under this process is Biogen’s Aduhelm (aducanumab). The drug, which was approved in June based on a secondary endpoint, has sparked endless controversy in the months since.
Galera: Endpoint Not Met in Severe Oral Mucositis (SOM)
One company not having a very good start to the week is Galera Therapeutics. After placing a big bet on its lead asset, avasopasem (GC4419), the drug failed to meet the primary endpoint in the Phase III ROMAN trial. While the study demonstrated relative reduction in all key SOM endpoints, including more than halving the median duration, patients in the treatment group saw just a small reduction of 54% in incidence compared to 64% in the placebo group.
The study consisted of 455 patients undergoing radiotherapy for head and neck cancer. SOM is an unfortunate and very unpleasant side effect of radiotherapy.
This pivotal trial was “laying the groundwork for the potential regulatory approval and commercialization of avasopasem,” Galera President and CEO Dr. Mel Sorensen, M.D. said upon completion of enrollment in June.
Sorensen added that Galera is still excited about the potential of its second dismutase mimetic product candidate, GC4711, which is in Phase I and II development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC) and locally advanced pancreatic cancer (LAPC).
Shares of Galera plummeted 73% on the news but experienced a small rebound Wednesday morning.
Potential New Weapon Against Acinetobacter baumannii Comes Up Big in Phase III
Entasis Therapeutics, AstraZeneca’s former anti-infectives unit, scored a big win in the battle against the simmering Antimicrobial resistance (AMR) pandemic. The company announced Tuesday that its lead antibiotic candidate has met the main objective of a pivotal study.
In Entasis’ global Phase III ATTACK study evaluating the safety and efficacy of SUL-DUR versus colistin, a last-resort treatment, the drug showed a statistically significant difference in clinical cure in 207 patients with carbapenem-resistant Acinetobacter infections. It is the first to achieve statistical non-inferiority in 28-day all-cause mortality in this population.
A group of bacteria commonly found in soil and water, Acinetobacter baumannii can cause infections in the blood, urinary tract, lungs and in wounds in other parts of the body.
The company is targeting a New Drug Application (NDA) submission date of mid-2022.
Castle Biosciences Snaps Up Cernostics For $30 Million
Texas-based dermatologic diagnostics company Castle BioSciences was feeling acquisitive this week in the AI space, buying Illumina Ventures’ Cernostics, which specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies.
The deal, worth $30 million upfront in cash-and-stock, also includes future contingent milestone payments in both forms of up to $50 million and is expected to expand Castle’s U.S. TAM by $1 billion. Upon news of the acquisition, Castle’s stock leaped 7.8% to close at $67.58 on Tuesday.
Cernostics’ TissueCypher® Barrett’s Esophagus Assay is the first precision medicine test that has been designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).
“Acquiring the TissueCypher platform is aligned with our commitment to utilizing innovative technology to provide clinically actionable information that guides disease management and improves patient outcomes,” stated Castle President and CEO Derek Maetzold.
Sana Locks in Beam Therapeutics’ CRISPR System for Ex Vivo Programs
Seattle-based Sana Biotechnology is upping its CRISPR game. The company announced Tuesday that it had entered into an agreement with Cambridge, Massachusetts-headquartered Beam Therapeutics, giving it non-exclusive commercial rights to Beam’s CRISPR Cas12b nuclease system for certain ex vivo engineered cell therapy programs.
The deal, which is worth $50 million upfront, will enable Sana to leverage Beam’s Cas12b system with select allogeneic T cell and stem cell-derived programs, as well as make gene edits for its hypoimmune platform. The license does not, however, allow Sana to do any base editing with the system.
“Gene editing technology is a key component in developing engineered cells as medicines, and we are pleased to have the ability to use the Cas12b system as part of a number of our ex vivo engineered cell programs,” said Sana President and CEO Steve Harr in a statement. “The specificity and efficiency of Cas12b make it appealing for Sana’s allogeneic T cell as well as gene-edited pluripotent stem cell programs. We intend to incorporate this platform into multiple product candidates, with the first IND filed as early as next year.”
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