Bibliographic Details
| Title: |
Avelumab in Combination With Lorlatinib or Crizotinib in Patients With Previously Treated Advanced NSCLC: Phase 1b/2 Results From the JAVELIN Lung 101 Trial |
| Authors: |
Benjamin J. Solomon, M.B.B.S., PhD, Ibiayi Dagogo-Jack, MD, Se-Hoon Lee, MD, Michael J. Boyer, M.B.B.S., PhD, Suresh S. Ramalingam, MD, Enric Carcereny, MD, Enriqueta Felip, MD, PhD, Ji-Youn Han, MD, PhD, Toyoaki Hida, PhD, Brett G.M. Hughes, M.B.B.S., Sang-We Kim, MD, PhD, Makoto Nishio, MD, PhD, Takashi Seto, MD, Tatsuro Okamoto, MD, PhD, Xiaoxi Zhang, PhD, Jean-Francois Martini, PhD, Erjian Wang, MD, PhD, Steven De Beukelaer, MD, Todd M. Bauer, MD |
| Source: |
JTO Clinical and Research Reports, Vol 5, Iss 7, Pp 100685- (2024) |
| Publisher Information: |
Elsevier, 2024. |
| Publication Year: |
2024 |
| Collection: |
LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| Subject Terms: |
Non–small cell lung cancer, Avelumab, Lorlatinib, Crizotinib, Phase 1b/2, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| More Details: |
Introduction: The JAVELIN Lung 101 phase 1b/2 trial evaluated avelumab (immune checkpoint inhibitor) combined with lorlatinib or crizotinib (tyrosine kinase inhibitors) in ALK-positive or ALK-negative advanced NSCLC, respectively. Methods: Starting doses of lorlatinib 100 mg once daily or crizotinib 250 mg twice daily were administered with avelumab 10 mg/kg every 2 weeks. Primary objectives were assessment of maximum tolerated dose (MTD) and recommended phase 2 dose in phase 1 and objective response rate in phase 2. Primary end points were dose-limiting toxicity (DLT) and confirmed objective response per Response Evaluation Criteria in Solid Tumors, version 1.1. Results: In the avelumab plus lorlatinib group (ALK-positive; n = 31; 28 in phase 1b; three in phase 2), two of 28 assessable patients (7%) had DLT, and the MTD and recommended phase 2 dose was avelumab 10 mg/kg every 2 weeks plus lorlatinib 100 mg once daily. In the avelumab plus crizotinib group (ALK-negative; n = 12; all phase 1b), five of 12 assessable patients (42%) had DLT, and the MTD was exceeded with avelumab 10 mg/kg every 2 weeks plus crizotinib 250 mg twice daily; alternative crizotinib doses were not assessed. Objective response rate was 52% (95% confidence interval, 33%–70%) with avelumab plus lorlatinib (complete response, 3%; partial response, 48%) and 25% (95% confidence interval, 6%–57%) with avelumab plus crizotinib (all partial responses). Conclusions: Avelumab plus lorlatinib treatment in ALK-positive NSCLC was feasible, but avelumab plus crizotinib treatment in ALK-negative NSCLC could not be administered at the doses tested. No evidence of increased antitumor activity was observed in either group. ClinicalTrials.gov identifier: NCT02584634 |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2666-3643 |
| Relation: |
http://www.sciencedirect.com/science/article/pii/S2666364324000559; https://doaj.org/toc/2666-3643 |
| DOI: |
10.1016/j.jtocrr.2024.100685 |
| Access URL: |
https://doaj.org/article/50d39c846b474baea88547c6b345e6aa |
| Accession Number: |
edsdoj.50d39c846b474baea88547c6b345e6aa |
| Database: |
Directory of Open Access Journals |
