Bennouna, J. (Jaafar)

Author search.filters.isAuthorOfPublication.38e68e93-6f95-4b2e-a1cc-66a2f8ba3dd7

Search Results

Now showing 1 - 1 of 1
  • Thumbnail Image
    Pembrolizumab After Two or More Lines of Previous Therapy in Patients With Recurrent or Metastatic SCLC: Results From the KEYNOTE-028 and KEYNOTE-158 Studies
    (Elsevier, 2020) Cheol-Chung, H. (Hyun); Piha-Paul, S. A. (Sarina A.); López-Martín, J.M. (José Manuel); Schellens, J.H.M (Jan H.M.); Kao, S. (Steven); Miller-Jr, W.H. (Wilson H.); Delord, J.P. (Jean-Pierre); Gao, B. (Bo); Planchard, D. (David); Gottfried, M. (Maya); Zer, A. (Alona); Jalal, S.I. (Shadia I.); Penel, N. (Nicolas); Mehnert, J.M. (Janice M.); Matos, I. (Ignacio); Bennouna, J. (Jaafar); Kim, D.W. (Dong Wan); Xu, L. (Lei); Krishnan, S. (Suba); Norwood, K. (Kevin); Ott, P.A. (Patrick A.)
    Introduction: Pembrolizumab has shown clinical benefit in patients with previously treated recurrent or metastatic SCLC in the phase 1b multicohort study KEYNOTE-028 (NCT02054806) and the phase 2 multicohort study KEYNOTE-158 (NCT02628067). We present a pooled analysis of patients from KEYNOTE-028 and KEYNOTE-158 who had received two or more lines of previous therapy for SCLC. Methods: Eligible patients were aged 18 years and above, had histologically or cytologically confirmed incurable recurrent or metastatic SCLC, had an Eastern Cooperative Oncology Group performance status of 1 and below, and had received two or more lines of previous therapy. Patients in KEYNOTE-028 were required to have a programmed death ligand 1 (PD-L1)-positive tumor. Patients received pembrolizumab (10 mg/kg every 2 weeks in KEYNOTE-028 or 200 mg every 3 weeks in KEYNOTE-158) for up to 2 years. The primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1, which is presented here per independent review. Results: Eighty-three patients who had received two or more lines of previous therapy (KEYNOTE-028, n = 19; KEYNOTE-158, n = 64) were included. Median follow-up duration was 7.7 (range, 0.5-48.7) months. Objective response rate was 19.3% (95% confidence interval: 11.4-29.4); two patients had complete response (one with a PD-L1-positive tumor), and 14 patients had partial response (13 with PD-L1-positive tumors). The median duration of response was not reached (range, 4.1‒35.8+ mo; plus sign indicates ongoing response); 61% of responders had responses lasting 18 months or longer. Fifty-one patients (61.4%) experienced any-grade treatment-related adverse events; eight patients (9.6%) had grade 3 or higher events. Conclusions: Pembrolizumab exhibited durable antitumor activity in a subset of patients with recurrent or metastatic SCLC who had undergone two or more previous lines of therapy, regardless of PD-L1 expression. Pembrolizumab was well tolerated.