Phase 3 Study of Pumitamig Versus Pembrolizumab in Previously Untreated Advanced Non-Small Cell Lung Cancer with PD-L1 ≥50%

The primary objective is to determine whether pumitamig provides better control of tumor growth and improves survival compared with pembrolizumab in previously untreated locally advanced or metastatic non-small cell lung cancer with PD-L1 expression of at least 50%. This is clinically relevant because it evaluates whether the investigational treatment offers superior disease control and life prolongation in a first-line setting. The secondary objectives are to assess how well pumitamig shrinks or eliminates tumors compared with pembrolizumab, how long these antitumor effects last, and how safe and tolerable each treatment is.

The trial enrolled 485 participants with non-small cell lung cancer. The study population included male and female patients aged 18 years and older. Participants were selected as patients with confirmed advanced-stage disease and documented high PD-L1 expression of at least 50%. They were required to be in good overall health and to have had no prior systemic anti-tumor therapy for advanced non-small cell lung cancer. No additional information on lifestyle considerations was provided.

ROSETTA Lung-202 is a randomized, double-blind, phase 3 trial comparing pumitamig monotherapy with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer and PD-L1 expression ≥ 50%. The study is designed to evaluate whether pumitamig provides better disease control and longer survival than the comparator. Eligible participants are adults with confirmed advanced NSCLC, documented high PD-L1 expression, good overall health, and no prior systemic anti-tumor therapy for advanced disease. The trial is planned to run from 2026-04-30 to 2031-10-26. Study participation includes a screening visit to assess eligibility, followed by treatment and follow-up visits for disease assessment, safety monitoring, and evaluation of response and tolerability, with an end-of-study visit at completion or discontinuation. Expected participant involvement extends through the treatment period and subsequent assessments until study completion. Early termination may occur if eligibility criteria are not met, if disease progression is documented, if unacceptable toxicity or safety concerns arise, or if other protocol-defined discontinuation conditions are met.

The investigational treatment consisted of pumitamig, supplied as a concentrate for solution for infusion in two presentations, BNT327 20 mg/ml and BNT327 50 mg/ml. Administration was by intravenous route. The study evaluated pumitamig monotherapy as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer with PD-L1 ≥ 50%.

The comparator treatment was pembrolizumab, administered as an intravenous infusion. The trial was a randomized, double-blind, Phase 3 study comparing pumitamig monotherapy with pembrolizumab. The available source data do not specify the exact dose, infusion schedule, or compliance monitoring procedures for either treatment.

Efficacy will be assessed by progression-free survival (PFS) as determined by BICR and by overall survival (OS). PFS will be evaluated by radiographic imaging techniques to measure the time until cancer progression. OS will be used to assess survival duration in participants receiving pumitamig compared with pembrolizumab. Overall response will also be assessed as a secondary efficacy endpoint.