Forster, M. (M.)
- Publications
- item.page.relationships.isContributorAdvisorOfPublication
- item.page.relationships.isContributorOfPublication
2 results
Search Results
Now showing 1 - 2 of 2
- Long-term follow-up in the KEYNOTE-010 study of pembrolizumab (pembro) for advanced NSCLC, including in patients (pts) who completed 2 years of pembro and pts who received a second course of pembro(Elsevier, 2018) Dubos-Arvis, C. (C.); Perez-Gracia, J.L. (Jose Luis); Kim, D.W; Baas, P. (P.); Lubiniecki, G.M (G. M.); Novello, S. (S.); Samkari, A. (A.); Chul-Cho, B. (B.); Su, W.C. (W. C.); Gubens, M.A. (M. A.); Han, J.Y. (J. Y.); Herbst, R.S. (Roy S.); Garon, E.B. (E. B.); Szalai, Z. (Z.); Majem-Tarruella, M. (Margarita); Ceresoli, G.L. (G. L.); Jensen, E.H. (E. H.); Forster, M. (M.); Monnet, I. (I.)In the global, open-label, phase 2/3 study KEYNOTE-010, pembro 10 mg/kg or 2 mg/kg Q3W improved OS vs docetaxel in pts with previously treated advanced NSCLC with PD-L1 TPS ≥50% and ≥1% (coprimary analyses) at median follow-up of 13.1 mo. We present long-term results overall, in pts who completed 35 cycles (∼2 y) of pembro, and in pts who received a second course of pembro.
- Five year survival update from KEYNOTE-010: pembrolizumab versus docetaxel for previously treated, programmed death-ligand 1-positive advanced NSCLC(Elsevier, 2021) Herbst, R.S. (Roy S.); Garon, E.B. (E. B.); Kim, D.W. (Dong Wan); Chul-Cho, B. (B.); Gervais, R. (Radj); Perez-Gracia, J.L. (Jose Luis); Han, J.Y. (Ji-Youn); Majem-Tarruella, M. (Margarita); Forster, M. (M.); Monnet, I. (I.); Novello, S. (Silvia); Gubens, M.A. (M. A.); Boyer, M. (Michael); Su, W.C. (W. C.); Samkari, A. (A.); Jensen, E.H. (E. H.); Kobie, J. (Julie); Piperdi, B. (Bilal); Baas, P. (Paul)Introduction: In the KEYNOTE-010 study, pembrolizumab improved overall survival (OS) versus docetaxel in patients with previously treated, advanced NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% and ≥1%. We report 5-year efficacy and safety follow-up for the KEYNOTE-010 study. Methods: Patients were randomized to pembrolizumab 2 mg/kg or 10 mg/kg once every 3 weeks or docetaxel 75 mg/m2 once every 3 weeks for up to 35 cycles (2 y). Patients who completed pembrolizumab treatment and subsequently had recurrence could receive second-course pembrolizumab for up to 17 cycles (1 y). Pembrolizumab doses were pooled in this analysis. Results: A total of 1034 patients were randomized (pembrolizumab, n = 691; docetaxel, n = 343). Median study follow-up was 67.4 months (range: 60.0‒77.9). The hazard ratio (95% confidence interval) for OS was 0.55 (0.44‒0.69) for patients with PD-L1 TPS ≥50% and 0.70 (0.61‒0.80) with PD-L1 TPS ≥1%. The 5-year OS rates for pembrolizumab versus docetaxel were 25.0% versus 8.2% in patients with PD-L1 TPS ≥50% and 15.6% versus 6.5% with PD-L1 TPS ≥1%. Among 79 patients who completed 35 cycles/2 years of pembrolizumab, the OS rate 3 years after completion (∼5 y from randomization) was 83.0%. A total of 21 patients received second-course pembrolizumab; 11 (52.4%) had an objective response after starting the second course and 15 (71.4%) were alive at data cutoff. Exploratory biomarker analysis revealed that higher tissue tumor mutational burden (≥175 mutations per exome) was associated with improved outcomes with pembrolizumab. Conclusions: Pembrolizumab continued to provide long-term benefit than docetaxel in patients with previously treated advanced NSCLC with PD-L1 TPS ≥50% and ≥1%. Our findings confirm pembrolizumab as a standard-of-care treatment in the second-line or later setting.