dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Callejo Perez, Ana |
dc.contributor.author | Berchem, Guy |
dc.contributor.author | Bazhenova, Lyudmila |
dc.contributor.author | Saintigny, Pierre |
dc.contributor.author | Felip Font, Enriqueta |
dc.contributor.author | Solomon, Benjamin |
dc.contributor.author | Bar, Jair |
dc.date.accessioned | 2022-08-12T10:47:07Z |
dc.date.available | 2022-08-12T10:47:07Z |
dc.date.issued | 2022-07 |
dc.identifier.citation | Solomon B, Callejo A, Bar J, Berchem G, Bazhenova L, Saintigny P, et al. A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer. Cancer Med. 2022 Jul;11(14):2790–800. |
dc.identifier.issn | 2045-7634 |
dc.identifier.uri | https://hdl.handle.net/11351/8001 |
dc.description | Genomics; Transcriptomics; Lung cancer |
dc.description.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. |
dc.language.iso | eng |
dc.publisher | Wiley |
dc.relation.ispartofseries | Cancer Medicine;11(14) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Pulmons - Càncer - Tractament |
dc.subject | Quimioteràpia combinada |
dc.subject.mesh | Carcinoma, Non-Small-Cell Lung |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols |
dc.title | A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1002/cam4.4635 |
dc.subject.decs | carcinoma de pulmón de células no pequeñas |
dc.subject.decs | /farmacoterapia |
dc.subject.decs | protocolos de quimioterapia antineoplásica combinada |
dc.relation.publishversion | https://doi.org/10.1002/cam4.4635 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Solomon B] Avera Cancer Institute, Sioux Falls, South Dakota, USA. [Callejo A, Felip E] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Bar J] Chaim Sheba Medical Center, Tel Hashomer, Israel. [Berchem G] Centre Hospitalier de Luxembourg, Luxembourg Institute of Health, Luxembourg City, Luxemburg. [Bazhenova L] University of California San Diego, Moores Cancer Center, San Diego, California, USA. [Saintigny P] Centre Léon Bérard, Cancer Research Center of Lyon, University of Lyon, Lyon, France |
dc.identifier.pmid | 35307972 |
dc.identifier.wos | 000776243800001 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |