Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355
Abstract Pembrolizumab plus chemotherapy improved progression‐free survival (PFS) and overall survival (OS) compared with placebo plus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple‐negative breast cancer with tumor programmed cell death ligand 1...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-05-01
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| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.5757 |
| _version_ | 1797817664509313024 |
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| author | Masaya Hattori Norikazu Masuda Toshimi Takano Koichiro Tsugawa Kenichi Inoue Koji Matsumoto Takashi Ishikawa Mitsuya Itoh Hiroyuki Yasojima Yuko Tanabe Keiko Yamamoto Masato Suzuki Wilbur Pan Javier Cortes Hiroji Iwata |
| author_facet | Masaya Hattori Norikazu Masuda Toshimi Takano Koichiro Tsugawa Kenichi Inoue Koji Matsumoto Takashi Ishikawa Mitsuya Itoh Hiroyuki Yasojima Yuko Tanabe Keiko Yamamoto Masato Suzuki Wilbur Pan Javier Cortes Hiroji Iwata |
| author_sort | Masaya Hattori |
| collection | DOAJ |
| description | Abstract Pembrolizumab plus chemotherapy improved progression‐free survival (PFS) and overall survival (OS) compared with placebo plus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple‐negative breast cancer with tumor programmed cell death ligand 1 (PD‐L1) combined positive score (CPS) ≥10 in the global, phase 3, randomized controlled trial KEYNOTE‐355. We report results for patients enrolled in Japan. Patients were randomized 2:1 to pembrolizumab 200 mg or placebo Q3W for 35 cycles plus chemotherapy (nab‐paclitaxel, paclitaxel, or gemcitabine–carboplatin). Primary endpoints were PFS per RECIST version 1.1 by blinded independent central review and OS in patients with PD‐L1 CPS ≥10, PD‐L1 CPS ≥1, and the intention‐to‐treat (ITT) population. No alpha was assigned to this exploratory analysis. Eighty‐seven patients were randomized in Japan (pembrolizumab plus chemotherapy, n = 61; placebo plus chemotherapy, n = 26), 66 (76%) had PD‐L1 CPS ≥1, and 28 (32%) had PD‐L1 CPS ≥10. Median time from randomization to data cutoff (June 15, 2021) was 44.7 (range, 37.2–52.9) months in the ITT population. Hazard ratios (HRs; 95% CI) for OS were 0.36 (0.14–0.89), 0.52 (0.30–0.91), and 0.46 (0.28–0.77) in the PD‐L1 CPS ≥10, PD‐L1 CPS ≥1, and ITT populations, respectively. HRs (95% CI) for PFS were 0.52 (0.20–1.34), 0.61 (0.35–1.06), and 0.64 (0.39–1.05). Grade 3 or 4 treatment‐related adverse events occurred in 85% of patients in each group (no grade 5 events). Consistent with the global population, pembrolizumab plus chemotherapy tended to show improvements in OS and PFS with manageable toxicity versus placebo plus chemotherapy in Japanese patients and supports this combination in this setting. |
| first_indexed | 2024-03-13T08:56:49Z |
| format | Article |
| id | doaj.art-d6b16a26e787415ab7f68851b17b9f97 |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-03-13T08:56:49Z |
| publishDate | 2023-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-d6b16a26e787415ab7f68851b17b9f972023-05-28T20:33:59ZengWileyCancer Medicine2045-76342023-05-01129102801029310.1002/cam4.5757Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355Masaya Hattori0Norikazu Masuda1Toshimi Takano2Koichiro Tsugawa3Kenichi Inoue4Koji Matsumoto5Takashi Ishikawa6Mitsuya Itoh7Hiroyuki Yasojima8Yuko Tanabe9Keiko Yamamoto10Masato Suzuki11Wilbur Pan12Javier Cortes13Hiroji Iwata14Aichi Cancer Center Hospital Nagoya JapanNagoya University Graduate School of Medicine Nagoya JapanThe Cancer Institute Hospital of JFCR Tokyo JapanSt. Marianna University Hospital Kawasaki JapanSaitama Cancer Center Saitama JapanHyogo Cancer Center Hyogo JapanTokyo Medical University Hospital Tokyo JapanHiroshima City Hiroshima Citizens Hospital Hiroshima JapanNational Hospital Organization Osaka National Hospital Osaka JapanToranomon Hospital Tokyo JapanMSD K.K. Tokyo JapanMSD K.K. Tokyo JapanMerck & Co., Inc. Rahway New Jersey USAInternational Breast Cancer Center (IBCC), Pangaea Oncology, Quironsalud Group, Madrid and Barcelona, Spain and Faculty of Biomedical and Health Sciences, Department of Medicine Universidad Europea de Madrid Madrid SpainAichi Cancer Center Hospital Nagoya JapanAbstract Pembrolizumab plus chemotherapy improved progression‐free survival (PFS) and overall survival (OS) compared with placebo plus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple‐negative breast cancer with tumor programmed cell death ligand 1 (PD‐L1) combined positive score (CPS) ≥10 in the global, phase 3, randomized controlled trial KEYNOTE‐355. We report results for patients enrolled in Japan. Patients were randomized 2:1 to pembrolizumab 200 mg or placebo Q3W for 35 cycles plus chemotherapy (nab‐paclitaxel, paclitaxel, or gemcitabine–carboplatin). Primary endpoints were PFS per RECIST version 1.1 by blinded independent central review and OS in patients with PD‐L1 CPS ≥10, PD‐L1 CPS ≥1, and the intention‐to‐treat (ITT) population. No alpha was assigned to this exploratory analysis. Eighty‐seven patients were randomized in Japan (pembrolizumab plus chemotherapy, n = 61; placebo plus chemotherapy, n = 26), 66 (76%) had PD‐L1 CPS ≥1, and 28 (32%) had PD‐L1 CPS ≥10. Median time from randomization to data cutoff (June 15, 2021) was 44.7 (range, 37.2–52.9) months in the ITT population. Hazard ratios (HRs; 95% CI) for OS were 0.36 (0.14–0.89), 0.52 (0.30–0.91), and 0.46 (0.28–0.77) in the PD‐L1 CPS ≥10, PD‐L1 CPS ≥1, and ITT populations, respectively. HRs (95% CI) for PFS were 0.52 (0.20–1.34), 0.61 (0.35–1.06), and 0.64 (0.39–1.05). Grade 3 or 4 treatment‐related adverse events occurred in 85% of patients in each group (no grade 5 events). Consistent with the global population, pembrolizumab plus chemotherapy tended to show improvements in OS and PFS with manageable toxicity versus placebo plus chemotherapy in Japanese patients and supports this combination in this setting.https://doi.org/10.1002/cam4.5757breast cancerchemotherapyclinical cancer researchclinical trials |
| spellingShingle | Masaya Hattori Norikazu Masuda Toshimi Takano Koichiro Tsugawa Kenichi Inoue Koji Matsumoto Takashi Ishikawa Mitsuya Itoh Hiroyuki Yasojima Yuko Tanabe Keiko Yamamoto Masato Suzuki Wilbur Pan Javier Cortes Hiroji Iwata Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355 Cancer Medicine breast cancer chemotherapy clinical cancer research clinical trials |
| title | Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355 |
| title_full | Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355 |
| title_fullStr | Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355 |
| title_full_unstemmed | Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355 |
| title_short | Pembrolizumab plus chemotherapy in Japanese patients with triple‐negative breast cancer: Results from KEYNOTE‐355 |
| title_sort | pembrolizumab plus chemotherapy in japanese patients with triple negative breast cancer results from keynote 355 |
| topic | breast cancer chemotherapy clinical cancer research clinical trials |
| url | https://doi.org/10.1002/cam4.5757 |
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