Yasushi Goto, MD, National Cancer Center Hospital, discusses primary efficacy findings from the phase 1 TROPION-Lung02 trial (NCT04526691) of datopotamab deruxtecan plus pembrolizumab (Keytruda) with or without platinum-based chemotherapy in patients with advanced non–small cell lung cancer (NSCLC).

TROPION-Lung02 included 6 cohorts, where patients received datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy intravenously every 3 weeks. In cohorts 1 and 2, datopotamab deruxtecan was given at 4-mg/kg and 6-mg/kg doses, respectively, with pembrolizumab given at 200 mg. In cohorts 3 and 4, datopotamab deruxtecan was given at dose levels of 4 mg/kg and 6 mg/kg, respectively, with pembrolizumab at 200 mg and carboplatin at an area under the curve of 5. Those in cohorts 5 and 6 received datopotamab deruxtecan at 4 mg/kg and 6 mg/kg, respectively, with pembrolizumab at 200 mg and cisplatin at 75 mg/m

In the entire patient population, the doublet elicited a confirmed and pending overall response rate (ORR) of 38%; with the triplet, this rate was 49%. Moreover, patients who received the doublet as first-line therapy had an ORR of 50%; those who received the triplet as first-line therapy had an ORR of 57%. The survival data, although immature, indicate efficacy with the doublet and triplet regimens, Goto says.

This multicohort phase 1 study includes a patient population with a variety of baseline characteristics, Goto notes. In total, 36%, 44%, and 20% of patients in the doublet cohort and 40%, 33%, and 25% of patients in the triplet cohort had a baseline PD-L1 expression of less than 1%, 1% to 49%, and at least 50%, respectively. Additionally, 17% and 19% of patients in the doublet and triplet cohorts, respectively had a history of brain metastases. Patients in both cohorts had a median of 0 prior lines of therapy (doublet, range, 0-4; triplet, range, 0-3).

Dr Goto reports honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb Japan, Chugai Pharma, Guardant Health AMEA, Kyowa Kirin International, Lilly Japan, Merck, MSD, Novartis, Ono Pharmaceutical, Pfizer, Shionogi, Taiho Pharmaceutical, Takeda, Thermo Fisher Scientific, and TOWA; consulting or advisory roles with AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo/UCB Japan GlaxoSmithKline, Guardant Health, AMEA, Janssen, Kyorin, Lilly, Merck, Novartis, Ono Pharmaceutical, Pfizer, and Taiho Pharmaceutical; and research funding from A2 Healthcare (Inst), AbbVie (Inst), AstraZeneca (Inst), Bristol-Myers Squibb Japan (Inst), Chugai Pharma (Inst), CMIC (Inst), Daiichi Sankyo (Inst), Daiichi Sankyo/UCB Japan (Inst), EPS Holdings (Inst), Genomic Health (Inst), IQvia (Inst), Kyorin (Inst), Lilly Japan (Inst), Merck Serono (Inst), MSD (Inst), Novartis (Inst), Ono Pharmaceutical (Inst), Pfizer (Inst), Taiho Pharmaceutical (Inst), and Takeda (Inst).

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Yasushi Goto, MD, discusses primary efficacy findings from the phase 1 TROPION-Lung02 trial of datopotamab deruxtecan plus pembrolizumab with or without platinum-based chemotherapy in patients with advanced non–small cell lung cancer.

Yasushi Goto, MD, PhD

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Dr Goto on Datopotamab Deruxtecan Plus Pembrolizumab and Chemotherapy in Advanced NSCLC