Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.
The biggest news of the week belongs to Novartis, which paused several trials of its CAR T candidate rapcabtagene autoleucel in autoimmune disease after the deaths of three patients taking the therapy. Bristol Myers Squibb followed suit, voluntarily freezing autoimmune trials for its own CAR T asset zolacabtagene autoleucel after observing “transient and reversible inflammatory events,” the company told William Blair, which broke the story.
On a more upbeat note, Revolution Medicines secured early FDA approval for a groundbreaking pancreatic cancer drug, now dubbed Rasonque. The greenlight is a big win not only for patients with the relentless and deadly disease, but also for the product’s chances in other indications, including first-line pancreatic cancer and non-small cell lung cancer. Truist Securities in a note last week went as far as to say that RevMed “remains on course to emerge as the next oncology titan.”
Unfortunately, the news wasn’t all positive in the cancer space last week. BioNTech discontinued a Phase 2 trial of its personalized mRNA cancer immunotherapy autogene cevumeran in colorectal cancer after an Independent Data Safety Monitoring Board determined that continuation would be futile. This almost immediately follows Merck & Moderna’s positive Phase 3 readout in melanoma last month—part of an overall resurgence for mRNA.
In other clinical trial struggles, AstraZeneca and Ionis’ Wainua failed more spectacularly in a Phase 3 trial in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) than originally reported. Detailed data revealed last week showed the hazard ratio in the trial was 1.14—meaning that patients had a 14% higher rate of cardiovascular mortality and recurrent clinical events versus the comparator arm.
Meanwhile, on the business front, nine midsize biopharma companies—including Astellas Pharma, BeOne Medicines and BridgeBio—have joined President Donald Trump’s Most Favored Nation drug pricing scheme, pledging to bring down the prices of their products to the same level as in similarly developed countries.
And finally, deals continue to soar as Eli Lilly picks up new therapeutic candidates for autoimmune and allergic diseases and Roche finds another oncology gem in Asia, inking an up to $1.5 billion partnership with China’s Simcere Zaiming.
