BioNTech lung cancer drug extends survival versus chemotherapy

BioNTech said its experimental drug gotistobart nearly doubled the median survival of patients with an aggressive form of lung cancer compared to chemotherapy.

Patients treated with gotistobart lived for a median 18.5 months, compared with 10 months for those given the standard-of-care chemotherapy, BioNTech said in a release Monday. The updated results are from a late-stage study evaluating patients with metastatic squamous nonsmall cell lung cancer whose disease progressed on prior immunotherapy and chemotherapy.

Earlier data showed that gotistobart reduced the risk of death by 54% compared to chemotherapy, though median overall survival wasn’t reached at the time.

“Current survival expectations with established therapies remain less than a year, and despite numerous development efforts, chemotherapy has remained the standard of care in this setting for more than a decade,” said Rama Balaraman, a principal investigator in the trial and medical oncologist.

If the survival benefit is confirmed in the next leg of the late-stage study, the drug could provide a chemotherapy-free option and “transform the standard of care” for this patient population, Balaraman added.

The results bolster BioNTech’s efforts to bring multiple cancer medicines to market by 2030 as sales of its COVID-19 vaccine decline. The German company is also undergoing a leadership transition, with co-founders Ugur Sahin and Ozlem Tureci preparing to leave the company by the end of the year for a new venture. Guido Oelkers is set to succeed Sahin as the company’s chief executive officer by February at the latest.

The company suffered a setback last month when it abandoned a study for a personalized vaccine for colorectal cancer patients. Hopes for the mRNA treatment had been raised by the success of rival drugmakers Moderna and Merck for a treatment of the same class for melanoma.

For gotistobart, BioNTech is collaborating with U.S. company OncoC4. The drug is designed to help the immune system attack cancer by removing cells that help tumors evade the body’s defenses. BioNTech said the safety profile of the drug was “consistent with previously reported data and remained manageable.”