Dr Fayette on the Efficacy of Petosemtamab Plus Pembrolizumab in Metastatic HNSCC 

Jerôme Fayette, MD, PhD, medical oncologist, Centre Léon Bérard, discusses findings from a phase 2 trial (NCT03526835) evaluating frontline petosemtamab (MCLA-158) plus pembrolizumab (Keytruda) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

This trial assessed the combination of petosemtamab and pembrolizumab in 24 efficacy-evaluable patients with previously untreated, recurrent or metastatic PD-L1–positive HNSCC with an ECOG performance status of 0 or 1 and measurable disease. The combination elicited an overall response rate (ORR) of 67% (95% CI, 45%-84%), including 1 complete response (CR), 12 partial responses (PRs), and 3 unconfirmed PRs. This ORR is numerically higher than the ORRs seen with TKIs and cetuximab (Erbitux) in this patient population, Fayette notes.

Response rates were similar between the HPV-positive and HPV-negative patient populations, as well as between the PD-L1–high and PD-L1–low populations, Fayette explains. In total, 42% of patients had a PD-L1 combined positive score (CPS) of 1 to 19, and 56% of patients had a PD-L1 CPS of 20 or higher. Among patients with low PD-L1 CPS, the ORR was 60%, with best responses of PD (n = 2), SD (n = 2), unconfirmed PR (n = 1), PR (n = 4), and CR (n = 1). In patients with high PD-L1 CPS, the ORR was 71%, with best responses of PD (n = 1), SD (n = 3), unconfirmed PR (n = 2), and PR (n = 8). Among patients with (57%) and without HPV type 16 (36%), the respective ORRs were 75% and 65%. Investigators observed no correlation between ORR and OS outcomes, Fayette notes.

Although longer follow-up data from this phase 2 trial are necessary to confirm the benefit of petosemtamab plus pembrolizumab in this patient population, current findings supported the initiation of a phase 3 registrational trial evaluating the combination vs pembrolizumab alone in the frontline setting, Fayette emphasizes. This trial is expected to begin at the end of 2024, Fayette concludes.

Videos

Jerôme Fayette, MD, PhD, discusses findings from a trial of frontline petosemtamab plus pembrolizumab in patients with recurrent/metastatic HNSCC.  

Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 study

Dr. Jérôme Fayette presents the findings of a phase 2 study (NCT03526835) assessing the overall response rate of petosemtamab in combination with pembrolizumab compared to pembrolizumab monotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma.

Petosemtamab (MCLA-158) With Pembrolizumab as First-line (1L) Treatment of Recurrent/Metastatic (r/m) Head and Neck Squamous Cell Carcinoma (HNSCC): Phase 2 Study

Jérôme Fayette, MD, PhD

Articles

Dr Fayette on the Efficacy of Petosemtamab Plus Pembrolizumab in Metastatic HNSCC

Petosemtamab (MCLA-158) With Pembrolizumab as First-line (1L) Treatment of Recurrent/Metastatic (r/m) Head and Neck Squamous Cell Carcinoma (HNSCC): Phase 2 Study