A global phase 2, open-label trial of pumitamig (PD-L1 × VEGF-A bsAb) + docetaxel post-chemoimmunotherapy in mNSCLC: First data from ROSETTA Lung-107

ROSETTA Lung-107

Patient / Population Intervention / Exposition Vergleich Endpunkt

In patients with metastatic NSCLC after chemoimmunotherapy, pumitamig plus docetaxel achieved a confirmed objective response rate of 36.7% with a manageable safety profile.

N

50Patienten

Design

Global, open-label, single-arm phase 2 trial of pumitamig plus docetaxel in patients with stage IV NSCLC after first-line chemoimmunotherapy, with measurable disease and ECOG PS ≤1, comprising a safety run-in/dose escalation part and a dose expansion part (NCT06841055).

Endpunkt

Dose-limiting toxicities (Part 1 only), safety and objective response rate.

ErgebnisConfirmed ORR 36.7% (11 of 30 response-evaluable patients): 42.9% with PD-L1 TPS <1%, 33.3% with TPS 1-49% and 40.0% with TPS ≥50%. Unconfirmed ORR 43.3%. DCR 90.0%. Median time to response 1.4 months (1.2-6.1). Median PFS 6.9 months (4.2-NR) at a median follow-up of 12.2 weeks. In the safety set (n=50), pumitamig-related TRAEs occurred in 52.0% (grade ≥3 18.0%) and led to discontinuation in 8.0%. Immune-mediated AEs occurred in 30.0% (grade ≥3 14.0%), VEGF-related events in 26.0% (grade ≥3 4.0%) and haemorrhage or bleeding in 16.0% (all grade 1/2). No DLTs were reported.

Cho BC, Williams A, Ozyilkan O, et al. Presented at ESMO Congress 2026, abstract LBA76, 25 October. Not yet published.

Diskussion & Kritik

This single-arm phase 2 study shows activity and acceptable early tolerability for pumitamig with docetaxel after chemoimmunotherapy. Without a docetaxel control arm, it cannot show how much pumitamig adds to chemotherapy. Only 30 of 50 treated patients were evaluable for response, median follow-up was 12.2 weeks and the PFS interval has no upper bound, so the efficacy data are immature, and overall survival is not reported. The PD-L1 subgroups hold between 5 and 18 patients each, too few to support conclusions about activity by PD-L1 level.