Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients With Untreated Metastatic EGFR-Mutated NSCLC: RELAY Japanese Subset
| Autor: | Yuichiro Ohe, Toshiaki Takahashi, Yoichi Nakanishi, Kazuko Sakai, Makoto Nishio, Martin Reck, Annamaria Zimmermann, Kazuto Nishio, Carla Visseren-Grul, Edward B. Garon, Takashi Seto, Terufumi Kato, Koichi Goto, Sotaro Enatsu, Bente Frimodt-Moller, Sameera R. Wijayawardana, Katsuyuki Kiura, Gosuke Homma, Nobuyuki Yamamoto, Kazuhiko Nakagawa, Rebecca R. Hozak, Tamura Tomohide |
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| Rok vydání: | 2021 |
| Předmět: |
Pulmonary and Respiratory Medicine
Oncology medicine.medical_specialty EGFR Population Placebo Ramucirumab T790M Japan Internal medicine medicine Non–small cell lung cancer education RC254-282 Circulating tumor DNA education.field_of_study business.industry Hazard ratio Neoplasms. Tumors. Oncology. Including cancer and carcinogens Confidence interval Discontinuation Erlotinib business medicine.drug |
| Zdroj: | JTO Clinical and Research Reports, Vol 2, Iss 6, Pp 100171-(2021) |
| ISSN: | 2666-3643 |
| Popis: | Introduction: The phase 3 RELAY global study (NCT02411448) revealed significant improvement in progression-free survival (PFS) with ramucirumab plus erlotinib (RAM + ERL) compared with placebo plus ERL (PL + ERL) in untreated EGFR-mutated metastatic NSCLC (hazard ratio [HR] = 0.59 [95% confidence interval (CI): 0.46–0.76, p < 0.0001]). This prespecified analysis evaluates efficacy, safety, and postprogression EGFR T790M rates of RELAY patients enrolled in Japan. Methods: Patients were randomized (1:1) to oral ERL (150 mg/d) plus intravenous RAM (10 mg/kg) or PL every 2 weeks. End points included PFS (primary), safety (secondary), and biomarker analyses (exploratory). Plasma samples collected at baseline and poststudy treatment discontinuation were evaluated for EGFR T790M mutations by next-generation sequencing. Results: The Japanese subset included 211 of 449 (47.0%) RELAY patients (RAM + ERL, n = 106; PL + ERL, n = 105). Median PFS was 19.4 versus 11.2 months for RAM + ERL versus PL + ERL treatment (HR = 0.610 [0.431–0.864]) in the Japanese intent-to-treat population, 16.6 versus 12.5 months (HR = 0.701 [0.424–1.159]) in the EGFR exon 19 deletion subgroup, and 19.4 versus 10.9 months (HR = 0.514 [0.317–0.835]) in the EGFR exon 21 L858R subgroup, respectively. Adverse events of grade 3 or above with RAM + ERL included hypertension (24.8%, all grade 3) and dermatitis acneiform (23.8%). Postprogression treatment-emergent T790M rates were similar between arms (RAM + ERL: 47%, 9 of 19 patients; PL + ERL: 50%, 20 of 40 patients). Conclusions: Clinically meaningful efficacy was observed with RAM + ERL versus PL + ERL in the RELAY Japanese subset, with no new safety concerns. Postprogression T790M rates were similar across treatment arms, indicating the addition of RAM did not affect the ERL-associated EGFR T790M rates at disease progression. |
| Databáze: | OpenAIRE |
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