Pumitamig pivotal trials come in pairs

Barely two months after posting two pivotal trials for their anti-PD-L1 x VEGF bispecific antibody pumitamig in gastrointestinal cancers, BioNTech and Bristol Myers Squibb have now added two more phase 3 studies, this time in lung cancer. The new entries on clinicaltrials.gov underscore the pace at which the programme and this space are moving.

The trials bring substance to the promises both companies made earlier this year. At the JP Morgan healthcare conference, Bristol said it expected to kick off three new pumitamig trials before the end of 2026, while BioNTech separately disclosed that, across oncology, it planned to initiate six new studies by year-end.

Both newly disclosed studies are sponsored by BioNTech and are scheduled to start in April, just one month after the gastrointestinal trials are due to get under way.

First-line maintenance

The first of the new studies, Rosetta-Lung201, mirrors the design of the Pacific trial that supported approval of AstraZeneca’s Imfinzi in stage III NSCLC. Rosetta-Lung201 will evaluate pumitamig head-to-head against Imfinzi in patients who have not relapsed following chemoradiotherapy.

This is a notoriously difficult setting. Since Imfinzi was approved on the back of Pacific multiple companies have attempted, and failed, to improve on these results. Among them is Bristol itself: an Opdivo and Yervoy combination missed the primary endpoint of progression-free survival in the Checkmate-73L trial.

Merck & Co is due to report data later this year from the Keylynk-012 trial, which is evaluating Keytruda in combination with Lynparza in the same indication. However, this PD-1/PARP inhibitor pairing has seen multiple disappointments through the years. 

Astra itself has so far failed to advance Imfinzi beyond this setting, failing in the first-line Pacific-2 trial. The UK company is attempting to raise the bar in first-line maintenance, though, with the Pacific-8 trial combining Imfinzi with Arcus and Gilead’s Tigit antibody domvanalimab; completion is expected in 2028.

PD-L1 ≥50%

Meanwhile, the second new pumitamig study, Rosetta-Lung202, will evaluate the PD-L1 x VEGF bispecific in an indication that other rivals in the space are already looking at. Among these is ivonescimab's Harmoni-7 trial, which started in early 2025 and is expected to be completed in 2028. 

Rosetta-Lung202 will be a head-to-head versus Keytruda in the first-line treatment of NSCLC patients with PD-L1 expression of at least 50%.

With these additions, there are now nine phase 3 trials posted on clinicaltrials.gov for pumitamig, although two are being conducted exclusively in China. One further pivotal study has yet to be posted: a first-line trial in head and neck cancer.

Pumitamig phase 3 trials in NSCLC

Source: OncologyPipeline.