Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
A Phase 2 Basket Trial of Ado-Trastuzumab Emtansine for Patients with HER2 Amplified Cancers: A Non-Randomized Clinical Trial.
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Ross Jessica S, Wong Winston, Schoech Lauren, Makhnin Alex, Liu Dazhi, Yllanes Ranieri, Loi Jonathan, Damrah Ala'A, Johnson Amanda, Ginsberg Michelle S, Jayaprakasam Vetri Sudar, Dunphy Mark, Shen Ronglai, Katabi Nora, Arora Kanika, Berger Michael F, Solit David B, Jeng Mark Y, Hsu Charles, Drilon Alexander, Makker Vicky, Iyer Gopakumar, Yaeger Rona, Riely Gregory J, Kris Mark G, Li Bob, Ho Alan, Chaft Jamie E
Аннотация
PURPOSE: To evaluate the efficacy of ado-trastuzumab emtansine (T-DM1) among patients with advanced/metastatic HER2-amplified solid tumors.
PATIENTS AND METHODS: This was a single-center, non-randomized phase 2 basket trial conducted at Memorial Sloan Kettering Cancer Center. All 95 patients had HER2-amplified metastatic/advanced disease and were enrolled in 1 of 5 cohorts. HER2 amplification was diagnosed either with next-generation sequencing or in-situ hybridization. All patients received intravenous T-DM1 3.6 mg/kg every 21 days. The primary endpoint was overall response rate (ORR). Overall survival (OS), progression-free survival (PFS), duration of response (DOR), and safety were secondary endpoints.
RESULTS: We treated 95 patients, and 22 (23% [95% CI, 16-33%]) had a confirmed response by investigator assessment. The investigator-assessed confirmed ORRs by cohort were: salivary 11/19 (58% [95% CI, 36-77%]); lung 4/23 (17% [95% CI, 7-37%]); colorectal 0/7 (0% [95% CI, 0-35%]); endometrial 5/23 (22% [95% CI, 10-42%]); "other" 2/23 (9% [95% CI, 2-27%]). Median PFS was 3.6 months (95% CI, 2.6-5.4) and ranged from 1.4 months in the "other" cohort to 10.2 months in the salivary cohort. Median OS was 11.9 months (95% CI, 8.4-17.2) and ranged from 7.8 months in the "other" cohort to 29.2 months in the salivary cohort. Median DOR was 13.1 months (95% CI, 7.3-30.5), ranging from 6.4 months in the lung cohort to 18.4 months in the "other" cohort.
CONCLUSIONS: T-DM1 demonstrated heterogenous efficacy among HER2-amplified tumor types, with promising response and outcomes among patients with salivary gland cancer.
PATIENTS AND METHODS: This was a single-center, non-randomized phase 2 basket trial conducted at Memorial Sloan Kettering Cancer Center. All 95 patients had HER2-amplified metastatic/advanced disease and were enrolled in 1 of 5 cohorts. HER2 amplification was diagnosed either with next-generation sequencing or in-situ hybridization. All patients received intravenous T-DM1 3.6 mg/kg every 21 days. The primary endpoint was overall response rate (ORR). Overall survival (OS), progression-free survival (PFS), duration of response (DOR), and safety were secondary endpoints.
RESULTS: We treated 95 patients, and 22 (23% [95% CI, 16-33%]) had a confirmed response by investigator assessment. The investigator-assessed confirmed ORRs by cohort were: salivary 11/19 (58% [95% CI, 36-77%]); lung 4/23 (17% [95% CI, 7-37%]); colorectal 0/7 (0% [95% CI, 0-35%]); endometrial 5/23 (22% [95% CI, 10-42%]); "other" 2/23 (9% [95% CI, 2-27%]). Median PFS was 3.6 months (95% CI, 2.6-5.4) and ranged from 1.4 months in the "other" cohort to 10.2 months in the salivary cohort. Median OS was 11.9 months (95% CI, 8.4-17.2) and ranged from 7.8 months in the "other" cohort to 29.2 months in the salivary cohort. Median DOR was 13.1 months (95% CI, 7.3-30.5), ranging from 6.4 months in the lung cohort to 18.4 months in the "other" cohort.
CONCLUSIONS: T-DM1 demonstrated heterogenous efficacy among HER2-amplified tumor types, with promising response and outcomes among patients with salivary gland cancer.