Bristol Myers Squibb Chief Medical Officer Cristian Massacesi, M.D., has told Fierce that the latest data for its BioNTech-partnered PD-L1xVEGF-A drug are “very promising,” as phase 3 ambitions ramp up.
The partners evaluated the PD-L1xVEGF-A bispecific immunomodulator, called pumitamig, alongside the chemotherapy drug docetaxel in the global phase 2 ROSETTA Lung-107 study. The trial enrolled patients with metastatic non-small cell lung cancer (NSCLC), regardless of PD-L1 expression levels, whose disease had progressed on or after first-line immunotherapy plus chemotherapy.
Among 30 evaluable patients, the confirmed objective response rate (ORR) was 36.7%, with a disease control rate (DCR) of 90%, the companies revealed in a presentation at the European Society for Medical Oncology (ESMO) Congress in Madrid.
Among the overall treated population of 50 patients, the companies reported median progression-free survival (PFS) of 6.9 months, with a six-month PFS rate of 63.3%.
Responses were observed across PD-L1 expression levels, according to the companies, with DCRs above 80% in all subgroups.
Massacesi told Fierce that the data supported the concept of pumitamig “not only replacing PD1 inhibitors, but expand[ing] the indication and the patient population where PD1 inhibitors are used, because they can work in tumors like colon cancer, where PD-1 inhibitors are not approved.”
“Based on this data, we are considering the next steps together with BioNTech to eventually run a pivotal project also in second-line [treatment],” he added.
When it came to safety, 18% of patients experienced a grade 3 or higher pumitamig-related adverse event, with four patients discontinuing treatment. VEGF-related events were reported in 26% of patients, with two experiencing grade 3 events. There were no pumitamig-related deaths or dose-limiting toxicities, the companies noted.
Massacesi described the safety profile as “manageable,” pointing out that bleeding events occurred in only 16% of patients and were limited to grades 1 and 2.
ESMO marked the third global phase 2 readout that BMS and BioNTech can use to promote pumitamig’s potential, following a small cell lung cancer trial and a China study, which both read out last year.
The partners have already taken the therapy into seven phase 3 trials spanning various types of lung, breast, colorectal and gastric cancer. Pumitamig is also being evaluated in more than 10 combination trials with other drugs, including antibody-drug conjugates.
BioNTech obtained full control over pumitamig through an $800 million-plus acquisition of its Chinese partner Biotheus in 2024 and attracted BMS as a co-development and co-commercialization partner the following year under a deal worth up to $11.1 billion.