Pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer in KEYNOTE‐407
The global phase III KEYNOTE‐407 (NCT02775435) trial showed that pembrolizumab plus chemotherapy prolonged overall and progression‐free survival (OS/PFS) versus placebo plus chemotherapy in patients with metastatic squamous non‐small‐cell lung cancer (NSCLC). We present outcomes of patients from Jap...
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| Veröffentlicht in: | Cancer science 2023-08, Vol.114 (8), p.3330-3341 |
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| creator | Sugawara, Shunichi Tanaka, Kentaro Imamura, Fumio Yamamoto, Nobuyuki Nishio, Makoto Okishio, Kyoichi Hirashima, Tomonori Tanaka, Hiroshi Fukuhara, Tatsuro Nakahara, Yasuharu Kurata, Takayasu Katakami, Nobuyuki Okada, Morihito Horinouchi, Hidehito Udagawa, Hibiki Kasahara, Kazuo Satouchi, Miyako Saka, Hideo Tokito, Takaaki Hosomi, Yukio Aoe, Keisuke Kishi, Kazuma Ohashi, Kadoaki Yokoyama, Takuma Adachi, Noriaki Noguchi, Kazuo Schwarzenberger, Paul Kato, Terufumi |
| description | The global phase III KEYNOTE‐407 (NCT02775435) trial showed that pembrolizumab plus chemotherapy prolonged overall and progression‐free survival (OS/PFS) versus placebo plus chemotherapy in patients with metastatic squamous non‐small‐cell lung cancer (NSCLC). We present outcomes of patients from Japan enrolled in KEYNOTE‐407. Patients were randomized 1:1 to receive pembrolizumab 200 mg or placebo with paclitaxel 200 mg/m2 every 3 weeks (Q3W) or nab‐paclitaxel 100 mg/m2 (weekly) plus carboplatin area under the concentration‐time curve of 6 mg/mL/min Q3W for four cycles, followed by pembrolizumab or placebo Q3W for a total of 35 cycles. Primary end‐points were OS and PFS per RECIST version 1.1 by blinded independent central review. Fifty patients were randomized at Japanese sites (pembrolizumab plus chemotherapy, n = 22; placebo plus chemotherapy, n = 28). Median follow‐up time at data cut‐off (May 9, 2019) was 15.1 (range, 0.5–24.0) months. Median OS (95% confidence interval [CI]) was 17.3 (12.5–not reached) versus 11.0 (8.6–19.5) months in the pembrolizumab plus chemotherapy versus placebo plus chemotherapy group (hazard ratio [HR] 0.56; 95% CI, 0.27–1.15). Median PFS (95% CI) was 8.3 (6.1–13.0) versus 7.2 (3.9–8.8) months (HR 0.65; 95% CI, 0.35–1.23). Grade 3–5 adverse events (AEs) occurred in 86% and 75% of patients, respectively. There were three fatal AEs, two of which were treatment‐related (one from each treatment group, pneumonitis and pulmonary hemorrhage). Efficacy and safety outcomes were consistent with the global study and support the use of pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous NSCLC.
Pembrolizumab plus platinum‐based chemotherapy prolonged overall survival and progression‐free survival, and provided durable clinical benefit with manageable safety versus placebo plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer (NSCLC) in the phase III KEYNOTE‐407 study. These data support the continued use of pembrolizumab plus platinum‐based chemotherapy as first‐line treatment for metastatic squamous NSCLC in Japanese patients. |
| doi_str_mv | 10.1111/cas.15816 |
| format | Article |
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Pembrolizumab plus platinum‐based chemotherapy prolonged overall survival and progression‐free survival, and provided durable clinical benefit with manageable safety versus placebo plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer (NSCLC) in the phase III KEYNOTE‐407 study. These data support the continued use of pembrolizumab plus platinum‐based chemotherapy as first‐line treatment for metastatic squamous NSCLC in Japanese patients.</description><identifier>ISSN: 1347-9032</identifier><identifier>EISSN: 1349-7006</identifier><identifier>DOI: 10.1111/cas.15816</identifier><identifier>PMID: 37183528</identifier><language>eng</language><publisher>England: John Wiley & Sons, Inc</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Cancer therapies ; Carboplatin ; carcinoma ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - etiology ; Chemotherapy ; clinical trial ; East Asian People ; Hemorrhage ; Humans ; immune checkpoint inhibitor ; immunotherapy ; Japan ; Ligands ; Lung cancer ; Lung diseases ; Lung Neoplasms - pathology ; Metastases ; Metastasis ; Non-small cell lung carcinoma ; non‐small‐cell lung cancer ; Original ; ORIGINAL ARTICLES ; Paclitaxel ; Patients ; Pembrolizumab ; Placebos ; Pneumonitis ; Radiation therapy ; Small cell lung carcinoma</subject><ispartof>Cancer science, 2023-08, Vol.114 (8), p.3330-3341</ispartof><rights>2023 Merck Sharp & Dohme LLC and The Authors. published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.</rights><rights>2023 Merck Sharp & Dohme LLC and The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.</rights><rights>2023. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4686-4c15fd92fd2dce4495aaa708d1a3b93e01ca6fd8a0485fee6025d0ac5f8cadfe3</citedby><cites>FETCH-LOGICAL-c4686-4c15fd92fd2dce4495aaa708d1a3b93e01ca6fd8a0485fee6025d0ac5f8cadfe3</cites><orcidid>0000-0001-8822-2684 ; 0000-0003-4969-4165 ; 0000-0002-5180-3933 ; 0000-0002-3427-4558 ; 0000-0001-9090-801X ; 0000-0002-1851-5788 ; 0000-0003-4123-3567</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10394135/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10394135/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1411,11541,27901,27902,45550,45551,46027,46451,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37183528$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sugawara, Shunichi</creatorcontrib><creatorcontrib>Tanaka, Kentaro</creatorcontrib><creatorcontrib>Imamura, Fumio</creatorcontrib><creatorcontrib>Yamamoto, Nobuyuki</creatorcontrib><creatorcontrib>Nishio, Makoto</creatorcontrib><creatorcontrib>Okishio, Kyoichi</creatorcontrib><creatorcontrib>Hirashima, Tomonori</creatorcontrib><creatorcontrib>Tanaka, Hiroshi</creatorcontrib><creatorcontrib>Fukuhara, Tatsuro</creatorcontrib><creatorcontrib>Nakahara, Yasuharu</creatorcontrib><creatorcontrib>Kurata, Takayasu</creatorcontrib><creatorcontrib>Katakami, Nobuyuki</creatorcontrib><creatorcontrib>Okada, Morihito</creatorcontrib><creatorcontrib>Horinouchi, Hidehito</creatorcontrib><creatorcontrib>Udagawa, Hibiki</creatorcontrib><creatorcontrib>Kasahara, Kazuo</creatorcontrib><creatorcontrib>Satouchi, Miyako</creatorcontrib><creatorcontrib>Saka, Hideo</creatorcontrib><creatorcontrib>Tokito, Takaaki</creatorcontrib><creatorcontrib>Hosomi, Yukio</creatorcontrib><creatorcontrib>Aoe, Keisuke</creatorcontrib><creatorcontrib>Kishi, Kazuma</creatorcontrib><creatorcontrib>Ohashi, Kadoaki</creatorcontrib><creatorcontrib>Yokoyama, Takuma</creatorcontrib><creatorcontrib>Adachi, Noriaki</creatorcontrib><creatorcontrib>Noguchi, Kazuo</creatorcontrib><creatorcontrib>Schwarzenberger, Paul</creatorcontrib><creatorcontrib>Kato, Terufumi</creatorcontrib><title>Pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer in KEYNOTE‐407</title><title>Cancer science</title><addtitle>Cancer Sci</addtitle><description>The global phase III KEYNOTE‐407 (NCT02775435) trial showed that pembrolizumab plus chemotherapy prolonged overall and progression‐free survival (OS/PFS) versus placebo plus chemotherapy in patients with metastatic squamous non‐small‐cell lung cancer (NSCLC). We present outcomes of patients from Japan enrolled in KEYNOTE‐407. Patients were randomized 1:1 to receive pembrolizumab 200 mg or placebo with paclitaxel 200 mg/m2 every 3 weeks (Q3W) or nab‐paclitaxel 100 mg/m2 (weekly) plus carboplatin area under the concentration‐time curve of 6 mg/mL/min Q3W for four cycles, followed by pembrolizumab or placebo Q3W for a total of 35 cycles. Primary end‐points were OS and PFS per RECIST version 1.1 by blinded independent central review. Fifty patients were randomized at Japanese sites (pembrolizumab plus chemotherapy, n = 22; placebo plus chemotherapy, n = 28). Median follow‐up time at data cut‐off (May 9, 2019) was 15.1 (range, 0.5–24.0) months. Median OS (95% confidence interval [CI]) was 17.3 (12.5–not reached) versus 11.0 (8.6–19.5) months in the pembrolizumab plus chemotherapy versus placebo plus chemotherapy group (hazard ratio [HR] 0.56; 95% CI, 0.27–1.15). Median PFS (95% CI) was 8.3 (6.1–13.0) versus 7.2 (3.9–8.8) months (HR 0.65; 95% CI, 0.35–1.23). Grade 3–5 adverse events (AEs) occurred in 86% and 75% of patients, respectively. There were three fatal AEs, two of which were treatment‐related (one from each treatment group, pneumonitis and pulmonary hemorrhage). Efficacy and safety outcomes were consistent with the global study and support the use of pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous NSCLC.
Pembrolizumab plus platinum‐based chemotherapy prolonged overall survival and progression‐free survival, and provided durable clinical benefit with manageable safety versus placebo plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer (NSCLC) in the phase III KEYNOTE‐407 study. These data support the continued use of pembrolizumab plus platinum‐based chemotherapy as first‐line treatment for metastatic squamous NSCLC in Japanese patients.</description><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Cancer therapies</subject><subject>Carboplatin</subject><subject>carcinoma</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - etiology</subject><subject>Chemotherapy</subject><subject>clinical trial</subject><subject>East Asian People</subject><subject>Hemorrhage</subject><subject>Humans</subject><subject>immune checkpoint inhibitor</subject><subject>immunotherapy</subject><subject>Japan</subject><subject>Ligands</subject><subject>Lung cancer</subject><subject>Lung diseases</subject><subject>Lung Neoplasms - pathology</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Non-small cell lung 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Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Biological Science Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sugawara, Shunichi</au><au>Tanaka, Kentaro</au><au>Imamura, Fumio</au><au>Yamamoto, Nobuyuki</au><au>Nishio, Makoto</au><au>Okishio, Kyoichi</au><au>Hirashima, Tomonori</au><au>Tanaka, Hiroshi</au><au>Fukuhara, Tatsuro</au><au>Nakahara, Yasuharu</au><au>Kurata, Takayasu</au><au>Katakami, Nobuyuki</au><au>Okada, Morihito</au><au>Horinouchi, Hidehito</au><au>Udagawa, Hibiki</au><au>Kasahara, Kazuo</au><au>Satouchi, Miyako</au><au>Saka, Hideo</au><au>Tokito, Takaaki</au><au>Hosomi, Yukio</au><au>Aoe, Keisuke</au><au>Kishi, Kazuma</au><au>Ohashi, Kadoaki</au><au>Yokoyama, Takuma</au><au>Adachi, Noriaki</au><au>Noguchi, Kazuo</au><au>Schwarzenberger, Paul</au><au>Kato, Terufumi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer in KEYNOTE‐407</atitle><jtitle>Cancer science</jtitle><addtitle>Cancer Sci</addtitle><date>2023-08</date><risdate>2023</risdate><volume>114</volume><issue>8</issue><spage>3330</spage><epage>3341</epage><pages>3330-3341</pages><issn>1347-9032</issn><eissn>1349-7006</eissn><abstract>The global phase III KEYNOTE‐407 (NCT02775435) trial showed that pembrolizumab plus chemotherapy prolonged overall and progression‐free survival (OS/PFS) versus placebo plus chemotherapy in patients with metastatic squamous non‐small‐cell lung cancer (NSCLC). We present outcomes of patients from Japan enrolled in KEYNOTE‐407. Patients were randomized 1:1 to receive pembrolizumab 200 mg or placebo with paclitaxel 200 mg/m2 every 3 weeks (Q3W) or nab‐paclitaxel 100 mg/m2 (weekly) plus carboplatin area under the concentration‐time curve of 6 mg/mL/min Q3W for four cycles, followed by pembrolizumab or placebo Q3W for a total of 35 cycles. Primary end‐points were OS and PFS per RECIST version 1.1 by blinded independent central review. Fifty patients were randomized at Japanese sites (pembrolizumab plus chemotherapy, n = 22; placebo plus chemotherapy, n = 28). Median follow‐up time at data cut‐off (May 9, 2019) was 15.1 (range, 0.5–24.0) months. Median OS (95% confidence interval [CI]) was 17.3 (12.5–not reached) versus 11.0 (8.6–19.5) months in the pembrolizumab plus chemotherapy versus placebo plus chemotherapy group (hazard ratio [HR] 0.56; 95% CI, 0.27–1.15). Median PFS (95% CI) was 8.3 (6.1–13.0) versus 7.2 (3.9–8.8) months (HR 0.65; 95% CI, 0.35–1.23). Grade 3–5 adverse events (AEs) occurred in 86% and 75% of patients, respectively. There were three fatal AEs, two of which were treatment‐related (one from each treatment group, pneumonitis and pulmonary hemorrhage). Efficacy and safety outcomes were consistent with the global study and support the use of pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous NSCLC.
Pembrolizumab plus platinum‐based chemotherapy prolonged overall survival and progression‐free survival, and provided durable clinical benefit with manageable safety versus placebo plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer (NSCLC) in the phase III KEYNOTE‐407 study. These data support the continued use of pembrolizumab plus platinum‐based chemotherapy as first‐line treatment for metastatic squamous NSCLC in Japanese patients.</abstract><cop>England</cop><pub>John Wiley & Sons, Inc</pub><pmid>37183528</pmid><doi>10.1111/cas.15816</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-8822-2684</orcidid><orcidid>https://orcid.org/0000-0003-4969-4165</orcidid><orcidid>https://orcid.org/0000-0002-5180-3933</orcidid><orcidid>https://orcid.org/0000-0002-3427-4558</orcidid><orcidid>https://orcid.org/0000-0001-9090-801X</orcidid><orcidid>https://orcid.org/0000-0002-1851-5788</orcidid><orcidid>https://orcid.org/0000-0003-4123-3567</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1347-9032 |
| ispartof | Cancer science, 2023-08, Vol.114 (8), p.3330-3341 |
| issn | 1347-9032 1349-7006 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10394135 |
| source | MEDLINE; Wiley Online Library Open Access; DOAJ Directory of Open Access Journals; Wiley Online Library Journals Frontfile Complete; PubMed Central |
| subjects | Antineoplastic Combined Chemotherapy Protocols - adverse effects Cancer therapies Carboplatin carcinoma Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - etiology Chemotherapy clinical trial East Asian People Hemorrhage Humans immune checkpoint inhibitor immunotherapy Japan Ligands Lung cancer Lung diseases Lung Neoplasms - pathology Metastases Metastasis Non-small cell lung carcinoma non‐small‐cell lung cancer Original ORIGINAL ARTICLES Paclitaxel Patients Pembrolizumab Placebos Pneumonitis Radiation therapy Small cell lung carcinoma |
| title | Pembrolizumab plus chemotherapy in Japanese patients with metastatic squamous non‐small‐cell lung cancer in KEYNOTE‐407 |
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