The Phase 2 lung-cancer data, released at 3:30 a.m. on Sunday, come from a single-arm study of 50 treated patients, 30 of whom could be assessed for response. Both stocks fell more than 1.7% on Friday, before the results.
Bristol Myers Squibb and BioNTech have given investors their first look at how their shared cancer drug performs in patients whose lung cancer has already beaten standard treatment.
In the Phase 2 ROSETTA Lung-107 study, presented at the European Society for Medical Oncology congress, pumitamig combined with the chemotherapy docetaxel produced a confirmed response rate of 36.7% among the 30 patients who could be evaluated, all with metastatic non-small cell lung cancer that had progressed after chemotherapy plus immunotherapy. Early median progression-free survival across all 50 treated patients was 6.9 months. The data cutoff was July 10, and median follow-up was about 12 weeks.
The companies described the data as encouraging.
Where it fits
The patients in the study had already received the current standard of first-line care for advanced lung cancer, a combination of chemotherapy and an immune checkpoint inhibitor. Docetaxel alone is a common next step for that group, and the question for pumitamig is whether adding it to docetaxel produces enough additional benefit to justify a new regimen.
A single-arm trial cannot answer that by itself. Without a control group, the 36.7% response rate can only be set against results from other studies, which used different patients and designs.
Small relative to the companies
For Bristol Myers, worth about $125.6 billion, a Phase 2 readout in a single setting is unlikely to change the investment case on its own. Its significance is as a step toward larger, randomized trials, which is where the drug's commercial value will be decided.
Bristol Myers closed Friday at $61.48, down 2.4%, and BioNTech at $88.12, down 1.7%. Both moves came before the data were released.
Two readings
The optimistic view is that a response rate above one-third in a pretreated population is a solid signal that supports moving into randomized Phase 3 trials.
The cautious view is that 30 evaluable patients, about three months of median follow-up and no comparison arm leave the drug's real advantage over docetaxel alone unknown, and that randomized results will decide its commercial value.
What to watch
Monday's trading in both stocks, any announcement of a Phase 3 program in this setting, and further pumitamig data at the rest of the congress, which runs through Oct. 27.