Bristol-Myers Squibb and BioNTech Advance New Phase 3 Lung Cancer Trial With Pumitamig

Biontech Se Sponsored Adr (BNTX), Bristol-Myers Squibb Company (BMY) announced an update on their ongoing clinical study.

Study Overview

The ROSETTA Lung-201 study is a Phase 3 trial comparing pumitamig with durvalumab in people with unresectable Stage III non-small cell lung cancer (NSCLC) who have already received combined chemotherapy and radiation. The official title describes a randomized, multicenter, open-label design focused on patients whose cancer has not worsened after platinum-based chemoradiation. The goal is to see if pumitamig can improve outcomes in this setting versus the current standard, durvalumab, which would be a meaningful shift in care for this large, high-need lung cancer group.

Intervention/Treatment

The study tests two drug treatments. The experimental drug is pumitamig (also known as BMS-986545), given alone after chemoradiation to help keep the cancer from coming back or getting worse. The control drug is durvalumab, a widely used immunotherapy that is the current standard maintenance option after chemoradiation in this type of lung cancer. Both are designed to help the immune system control or slow the cancer.

Study Design

This is an interventional Phase 3 study with patients randomly assigned to one of two groups: pumitamig or durvalumab. The model is parallel, meaning each group gets only its assigned drug throughout the trial. There is no masking or blinding; doctors and patients know which treatment is given. The main purpose is treatment, aiming to show whether pumitamig offers better or at least comparable benefit to durvalumab in this setting.

Study Timeline

The study was first submitted on January 21, 2026, and is listed as not yet recruiting, indicating that sites and systems are being set up ahead of enrolling patients. The same date, January 21, 2026, is also the last update submitted, suggesting this is a very recent listing with no results yet available. Primary completion and final completion dates are not specified in the record, but Phase 3 lung cancer trials of this type often run several years before key readouts, so investors should view this as a long-term value driver rather than a near-term catalyst.

Market Implications

For Bristol-Myers Squibb, pumitamig represents a potential way to expand its immuno-oncology portfolio into a core lung cancer segment now anchored by competitors such as AstraZeneca’s durvalumab. A positive outcome could support new revenue streams and partly offset pricing pressure and patent risk in other areas of the portfolio. For BioNTech, co-sponsorship reflects a strategy to diversify beyond vaccines into solid tumor immunotherapy, adding another late-stage asset to its pipeline narrative. In the near term, the listing itself is unlikely to move either stock, but it strengthens the story that both firms are investing in durable oncology growth. Investors may watch this trial alongside other NSCLC programs as a signal of how the post-chemoradiation maintenance market evolves and how competition shapes long-run pricing and market share dynamics.

ROSETTA Lung-201 is an active, newly listed Phase 3 study, and investors can track future updates and detailed information on the ClinicalTrials.gov portal.

To learn more about BNTX’s potential, visit the Biontech Se Sponsored Adr drug pipeline page.