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Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer
Leena Gandhi1, Delvys Rodríguez-Abreu1, Shirish Gadgeel1
1From NYU Perlmutter Cancer Center, New York (L.G.); Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria (D.R.-A.), Hospital Universitario Central de Asturias, Oviedo (E.E.), Vall d'Hebron University, Vall d'Hebron Institute of Oncology, Barcelona (E.F.), and Fundación Jiménez Díaz (M.D.) and Hospital Universitario Quirón Madrid (B.R.-V.), Madrid - all in Spain; Karmanos Cancer Institute, Detroit (S.G.); Integrated Health and Social Services Centres, Montérégie Centre, Greenfield Park, QC (F.D.A.), and Sunnybrook Health Sciences Centre, Toronto (S.Y.-S.C.) - both in Canada; Southern Medical Day Care Centre, Wollongong, NSW (P.C.), Epworth Healthcare, Richmond, VIC (R.R.J.), Westmead Hospital and University of Sydney, Sydney (R.H.), and Chris O'Brien Lifehouse, Camperdown, NSW (M.B.) - all in Australia; Otto Wagner Hospital, Vienna (M.J.H.); Sanford Health, Sioux Falls, SD (S.F.P.); Thoraxklinik, Heidelberg (H.G.B.), and LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf (M.R.) - both in Germany; Davidoff Cancer Center, Tel Aviv University, Petah Tikva, Israel (N.P.); Ospedale Policlinico San Martino, Genoa (F.G.), University of Turin, Azienda Ospedaliero-Universitaria San Luigi, Orbassano (S.N.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.C.G.) - all in Italy; David Geffen School of Medicine at UCLA, Los Angeles (E.B.G.); Kansai Medical University Hospital, Osaka, Japan (T.K.); Moffitt Cancer Center, Tampa, FL (J.E.G.); and Merck, Kenilworth, NJ (J.V., Z.W., J.Y., H.R., M.C.P.).
Pembrolizumab combined with chemotherapy significantly improves survival for advanced non-small-cell lung cancer (NSCLC) patients lacking targetable mutations. This combination therapy offers a superior treatment option compared to chemotherapy alone, enhancing both overall and progression-free survival rates.
Area of Science:
- Oncology
- Immunotherapy
- Pharmacology
Background:
- Platinum-based chemotherapy is the standard first-line treatment for advanced non-small-cell lung cancer (NSCLC) without targetable mutations.
- Pembrolizumab is established as a first-line treatment for NSCLC with a programmed death ligand 1 (PD-L1) tumor proportion score of 50% or greater.
- Previous phase 2 trials indicated that adding pembrolizumab to chemotherapy improves response rates and progression-free survival.
Purpose of the Study:
- To evaluate the efficacy and safety of adding pembrolizumab to standard chemotherapy in patients with previously untreated metastatic nonsquamous NSCLC.
- To compare overall survival (OS) and progression-free survival (PFS) between the pembrolizumab-chemotherapy combination and chemotherapy alone.
Main Methods:
- A double-blind, phase 3 trial randomized 616 patients with metastatic nonsquamous NSCLC (no EGFR/ALK mutations, no prior metastatic treatment) to pemetrexed/platinum plus pembrolizumab or placebo.
- Treatment involved 4 cycles followed by maintenance therapy for up to 35 cycles.
- Primary endpoints were OS and PFS, assessed by blinded, independent central radiologic review.
Main Results:
- At 12 months, the overall survival rate was 69.2% in the pembrolizumab group versus 49.4% in the placebo group (hazard ratio for death, 0.49; P<0.001).
- Median progression-free survival was 8.8 months with pembrolizumab versus 4.9 months with placebo (hazard ratio for progression or death, 0.52; P<0.001).
- Grade 3 or higher adverse events were similar: 67.2% in the pembrolizumab group and 65.8% in the placebo group.
Conclusions:
- Adding pembrolizumab to pemetrexed and a platinum-based drug significantly improves overall survival and progression-free survival in patients with previously untreated metastatic nonsquamous NSCLC.
- The survival benefit was observed across all evaluated PD-L1 expression levels.
- The combination therapy represents a new standard of care for this patient population.
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