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- Title
A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non‐small cell lung cancer.
- Authors
Solomon, Benjamin; Callejo, Ana; Bar, Jair; Berchem, Guy; Bazhenova, Lyudmila; Saintigny, Pierre; Wunder, Fanny; Raynaud, Jacques; Girard, Nicolas; Lee, J. Jack; Sulaiman, Raed; Prouse, Bruce; Bresson, Catherine; Ventura, Hila; Magidi, Shai; Rubin, Eitan; Young, Brandon; Onn, Amir; Leyland‐Jones, Brian; Schilsky, Richard L.
- Abstract
Background: The Worldwide Innovative Network (WIN) Consortium has developed the Simplified Interventional Mapping System (SIMS) to better define the cancer molecular milieu based on genomics/transcriptomics from tumor and analogous normal tissue biopsies. SPRING is the first trial to assess a SIMS‐based tri‐therapy regimen in advanced non‐small cell lung cancer (NSCLC). Methods: Patients with advanced NSCLC (no EGFR, ALK, or ROS1 alterations; PD‐L1 unrestricted; ≤2 prior therapy lines) received avelumab, axitinib, and palbociclib (3 + 3 dose escalation design). Results: Fifteen patients were treated (five centers, four countries): six at each of dose levels 1 (DL1) and DL2; three at DL3. The most common ≥Grade 3 adverse events were neutropenia, hypertension, and fatigue. The recommended Phase II dose (RP2D) was DL1: avelumab 10 mg/kg IV q2weeks, axitinib 3 mg po bid, and palbociclib 75 mg po daily (7 days off/21 days on). Four patients (27%) achieved a partial response (PR) (progression‐free survival [PFS]: 14, 24, 25 and 144+ weeks), including two after progression on pembrolizumab. Four patients attained stable disease (SD) that lasted ≥24 weeks: 24, 27, 29, and 64 weeks. At DL1 (RP2D), four of six patients (66%) achieved stable disease (SD) ≥6 months/PR (2 each). Responders included patients with no detectable PD‐L1 expression and low tumor mutational burden. Conclusions: Overall, eight of 15 patients (53%) achieved clinical benefit (SD ≥ 24 weeks/PR) on the avelumab, axitinib, and palbociclib combination. This triplet showed antitumor activity in NSCLC, including in tumors post‐pembrolizumab progression, and was active at the RP2D, which was well tolerated. NCT03386929 clinicaltrial.gov
- Subjects
NON-small-cell lung carcinoma
- Publication
Cancer Medicine, 2022, Vol 11, Issue 14, p2790
- ISSN
2045-7634
- Publication type
Article
- DOI
10.1002/cam4.4635