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Roche's Divarasib Beat Both Approved KRAS Pills Head-to-Head, and Patients Lived Longer
KRAS G12C is a mutation that drives some lung cancers, and sotorasib and adagrasib are the approved first-generation pills that target it. Roche's Phase 3 Krascendo 1 trial pitted its newer drug, divarasib, against both in 338 previously treated patients. Divarasib cut the risk of death by 44%. Patients lived a median of 17.7 months, nearly six months longer than on the older pills. They also stayed on treatment more than twice as long, yet serious treatment-related side effects were about half as common (7.8% versus 15.2%). The data were presented at ESMO in Madrid and published in the New England Journal of Medicine.
Why it matters: The study's lead author, Ferdinandos Skoulidis, called divarasib the first KRAS inhibitor to meaningfully improve survival in this setting. That makes it the drug to beat: for anyone else in the KRAS race, matching the first-generation pills is no longer enough.
Roche →Clinical & Regulatory
Amgen's Imdelltra Cut the Risk of Death by 58% in Small Cell Lung Cancer
Imdelltra is approved only after platinum chemo stops working; Amgen wants it much earlier. In the Phase 3 DeLLphi-305 trial, 563 patients with extensive-stage small cell lung cancer got it plus Imfinzi, or Imfinzi alone, as maintenance after first-line chemo. The combination cut the risk of death by 58%, and median survival rose to 21.1 months from 12.7. The trade-off: severe (grade 3 or worse) treatment-related side effects roughly doubled, to 20.9% from 10.8%.
Amgen →Moderna and Merck's Personalized Cancer Vaccine Delivered. The Stock Fell Anyway.
Intismeran is made from each patient's own sequenced tumor. Given after melanoma surgery, it cut the risk of recurrence or death by 42% in Phase 3, a result RBC called "clinically meaningful and likely approvable." Moderna shares still fell by double digits when the results came out early. Investors worry about scale, a median 64-day wait for the first dose, and whether it works beyond melanoma; lung, kidney and bladder readouts come next.
BioPharma Dive →Deals & Money
An Oral GLP-1 for the Merely Overweight Goes Public via SPAC
Corxel is going public by merging with Amanat Acquisition Corp., a blank-check company, with a $300 million private investment alongside. It brings CX11, an oral GLP-1 licensed from China's Vincentage Pharma, which produced average weight loss of up to 11.5% at 36 weeks in a U.S. Phase 2. It trails pills already on the market, so Corxel is aiming at people who need to lose 5% to 10% of their weight.
BioPharma Dive →Bambusa Wants $150 Million for Bispecifics Licensed From BioNTech's China Arm
Bambusa, founded in 2024, set terms for a $150 million Nasdaq IPO, valuing it at about $837 million at the midpoint. Its lead drug, BBT001, is a bispecific antibody (one molecule, two targets) aimed at IL-4Rα and IL-31 and still in Phase 1 for atopic dermatitis. If it prices this week as expected, it is another test of investors' appetite for China-sourced immunology drugs.
Renaissance Capital →Science
A Brand-New Kind of Drug Shrank Prostate Tumors in 12 of 16 Patients
JNJ-6143, from J&J's Halda buyout, is the first molecule from its RIPTAC platform to reach patients: a daily pill that locks BRD4, a protein cells need to survive, onto the androgen receptor, which prostate tumors make in abundance. In heavily pretreated patients at the 50 mg dose, tumors shrank in 12 of 16 with measurable disease, and 77% saw PSA fall by at least half. It is early Phase 1 data, and J&J is taking the 50 mg dose into Phase 2.
Johnson & Johnson →