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Safety and Clinical Activity of a New Anti-PD-L1 Antibody as Monotherapy or Combined with Targeted Therapy in Advanced Solid Tumors: The PACT Phase Ia/Ib Trial
DC Field | Value | Language |
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dc.contributor.author | Patnaik, Amita | - |
dc.contributor.author | Yap, Timothy A. | - |
dc.contributor.author | Chung, Hyun Cheol | - |
dc.contributor.author | de Miguel, Maria J. | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Lin, Chia-Chi | - |
dc.contributor.author | Su, Wu-Chou | - |
dc.contributor.author | Italiano, Antoine | - |
dc.contributor.author | Chow, Kay Hoong | - |
dc.contributor.author | Szpurka, Anna M. | - |
dc.contributor.author | Yu, Danni | - |
dc.contributor.author | Zhao, Yumin | - |
dc.contributor.author | Carlsen, Michelle | - |
dc.contributor.author | Schmidt, Shelly | - |
dc.contributor.author | Vangerow, Burkhard | - |
dc.contributor.author | Gandhi, Leena | - |
dc.contributor.author | Xu, Xiaojian | - |
dc.contributor.author | Bendell, Johanna | - |
dc.date.accessioned | 2022-04-18T09:24:35Z | - |
dc.date.available | 2022-04-18T09:24:35Z | - |
dc.date.created | 2021-03-31 | - |
dc.date.created | 2021-03-31 | - |
dc.date.created | 2021-03-31 | - |
dc.date.created | 2021-03-31 | - |
dc.date.issued | 2021-03-01 | - |
dc.identifier.citation | Clinical Cancer Research, Vol.27 No.5, pp.1267-1277 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.other | 127025 | - |
dc.identifier.uri | https://hdl.handle.net/10371/178110 | - |
dc.description.abstract | Purpose: This phase Ia/Ib PACT study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of a new programmed cell death ligand 1 (PD-L1) inhibitor, LY3300054, as monotherapy or in combination with ramucirumab, abemaciclib, or merestinib (a type II MET kinase inhibitor) in patients with advanced, refractory solid tumors (NCT02791334). Patients and Methods: Patients were enrolled into cohorts of escalating LY3300054 dose (phase Ia) as monotherapy (N = 15) or combined with ramucirumab (N = 10), abemaciclib (N = 24), or merestinib (N = 12). The phase Ib dose expansion enrolled 8 patients with melanoma in the monotherapy arm and 12 patients with pancreatic cancer in the merestinib combination arm. Combination treatments were administered concurrently from day 1 of each cycle. A 14-day lead-in abemaciclib arm was also explored. Primary endpoints were dose-limiting toxicity (DLT) and safety. Results: Treatment-related adverse events included fatigue and nausea in the monotherapy arm (13% for each), hypothyroidism (30%) in the ramucirumab arm, diarrhea (54%) in the abemaciclib arm, and nausea (25%) in the merestinib arm. DLTs associated with hepatoxicity were observed in 3 of 4 patients in the abemaciclib leadin cohorts. No DLTs or grade 3 or 4 hepatoxicity were reported in the concurrent abemaciclib arm. Pharmacokinetic characteristics were comparable with other PD-L1 inhibitors. One patient in each arm experienced a partial response per RECIST v1.1 lasting >= 7 months. Conclusions: LY3300054 was well tolerated without unexpected safety concerns when administered alone or concurrently with ramucirumab, abemaciclib, or merestinib. Lead-in abemaciclib before combining with LY3300054 was not feasible due to hepatotoxicity. Durable clinical benefits were seen in all regimens. | - |
dc.language | 영어 | - |
dc.publisher | American Association for Cancer Research | - |
dc.title | Safety and Clinical Activity of a New Anti-PD-L1 Antibody as Monotherapy or Combined with Targeted Therapy in Advanced Solid Tumors: The PACT Phase Ia/Ib Trial | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-20-2821 | - |
dc.citation.journaltitle | Clinical Cancer Research | - |
dc.identifier.wosid | 000625367700008 | - |
dc.identifier.scopusid | 2-s2.0-85102516128 | - |
dc.citation.endpage | 1277 | - |
dc.citation.number | 5 | - |
dc.citation.startpage | 1267 | - |
dc.citation.volume | 27 | - |
dc.identifier.sci | 000625367700008 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | CELL LUNG-CANCER | - |
dc.subject.keywordPlus | IMMUNE CHECKPOINT BLOCKADE | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | ATEZOLIZUMAB | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | BEVACIZUMAB | - |
dc.subject.keywordPlus | ABEMACICLIB | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | COMBINATION | - |
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