PO.CTP01.03 · 进行中的临床试验

Palbociclib (P) in patients (pts) with lung cancer (LC) with CCND1 amplification (amp): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

编号 CT211 展板 6 时间 4/21 09:00–12:00 区域 Section 51 主讲 Evan Pisick, MD

分会场 Phase II and Phase III Clinical Trials in Progress

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作者与单位

Evan Pisick¹, Michael Rothe², Elizabeth Garrett-Mayer², Christopher M. Reynolds³, Bamidele Adesunloye⁴, Ramya Thota⁵, Kathryn F. Mileham⁶, Kelly Lynch⁷, Rachel E. Sanborn⁸, Timothy L. Cannon⁹, Justin T. Moyers¹⁰, Janet Tu¹¹, Mehmet Akce¹², Abigail Gregory², Dominique C. Hinshaw², Gina N. Grantham², Susan Halabi¹³, Richard L. Schilsky²

¹City of Hope - Chicago, Zion, IL,²American Society of Clinical Oncology, Alexandria, VA,³Michigan Cancer Research Consortium, Ypsilanti, MI,⁴City of Hope - Atlanta, Atlanta, GA,⁵Intermountain Healthcare, Murray, UT,⁶Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NC,⁷Cancer Research Consortium of West Michigan, Norton Shores, MI,⁸Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR,⁹Inova Schar Cancer Institute, Fairfax, VA,¹⁰The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Los Angeles, CA,¹¹Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX,¹²O’Neal Comprehensive Cancer Center, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, AL,¹³Duke University Medical Center, Durham, NC

摘要 Abstract

Background: TAPUR is a phase II basket study evaluating antitumor activity of commercially available targeted agents in pts with advanced cancers with specific genomic alterations. Results in a cohort of pts with LC with CCND1 amp treated with P are reported. Methods: Eligible pts had non-small cell (NSCLC) or small cell (SCLC) LC, measurable disease, ECOG performance status (PS) 0-2, adequate organ function, and no remaining standard treatment (tx) options. Genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Amp cut-offs were defined per NGS providers. Tumors must not have had mutations (mut) in the RB gene. P dosing was one 125 mg capsule taken orally once daily for 21 days followed by 7 days off, until disease progression. Primary endpoint was disease control (DC) per investigator defined as objective response (OR) or stable disease (SD) of at least 16+ weeks (wks) duration (SD16+) per RECIST v1.1. Simon 2-stage design tested the null DC rate of 15% vs. 35% (power = 0.85; alpha = 0.10). Secondary endpoints were progression-free survival (PFS), overall survival (OS), OR, duration of SD, and safety. Results: 29 pts with NSCLC (n=28) or SCLC (n=1) with CCND1 amp (n=28) or CCND1 amp and mut (n=1) were enrolled. Co-alterations in KRAS and CDKN2A/B included: KRAS mut (n=2), amp (n=2), and mut and amp (n=1); CDKN2A mut (n=6), deletion (del; n=1), and mut and del (n=1). 1 pt with NSCLC was unevaluable for efficacy. Table shows demographics, outcomes, and toxicity. SD16+ was observed in 5 pts, all with NSCLC and CCND1 amp for a DC rate of 25% (1-sided 90% CI, 10 to 100) and an OR rate of 0% (95% CI, 0 to 12). The null DC rate was not rejected (p=0.28). 4 pts had ≥1 grade 3-4 tx-related adverse events (AE) or serious adverse events (SAE). Conclusions: P did not meet prespecified criteria to declare a signal of activity in pts with LC with CCND1 amp. Other tx should be considered for these pts, including tx offered in clinical trials. Table: Demographics, Toxicity (N=29), and Efficacy Outcomes (n=28) Median (Med) age, years (range) 63 (34, 84) Female, No. (%) 11 (38) ECOG PS, No. (%) 0 4 (14) 1 20 (69) 2 5 (17) Prior systemic regimens, No. (%) 1 1 (3) 2 8 (28) ≥3 20 (69) DC rate, % (OR or SD16+) (1-sided 90% CI), p-value 25 (10, 100), p = 0.28 OR rate, % (95% CI) 0 (0, 12) Med PFS, wks (95% CI) 9 (7, 16) Med OS, wks (95% CI) 25 (17, 41) Med duration SD in pts with SD16+ (range), wks 25 (16-30) Number of pts 1 with tx-related AE or SAE (grade 3-4) AE 2 4 (14) SAE 3 1 (3) 1 Patients may have experienced one or more events 2 Leukopenia, lymphopenia, neutropenia, pain 3 Sepsis

利益披露 Disclosure

E. Pisick, None.. M. Rothe, None.. E. Garrett-Mayer, None.. C. M. Reynolds, None. B. Adesunloye, Eisai Other, Advisory Board. Pfizer Other, Advisory Board. Exellixis Other, Advisory Board. R. Thota, None. K. F. Mileham, Abbvie Independent Contractor, Other, Advisory board. Astra Zeneca Independent Contractor, Other, Advisory board. Bayer Independent Contractor, Other, Advisory Board. Genentech Independent Contractor, Other, Advisory Board. Janssen Independent Contractor, Other, Advisory Board. Merck Independent Contractor, Other, Advisory Board. Nuvation Bio Independent Contractor, Other, Advisory Board. Takeda Independent Contractor, Other, Advisory Board. Tempus ). K. Lynch, None. R. E. Sanborn, AstraZeneca, Bristol Myers Squibb, Merck ). Abbive, Amgen, AstraZeneca, BeiGene, Boehringer Ingelheim, Curio Science, Daiichi Sankyo, G1 Therapeutics, GE Healthcare, Gilead Sciences, IDEOlogy Health, Illumina, InhibRx, Janssen Oncology Independent Contractor. Johnson & Johnson/Janssen, Lilly Oncology, Natera, OncLive/MJH Life Sciences, OSE Immunotherapies, Pfizer, Rigel, Sanofi/Aventis, Targeted Oncology Independent Contractor. Amgen, AstraZeneca, G1 Therapeutics, GE Healthcare, Gilead Sciences, GlaxoSmithKline, Janssen Oncology, Sanofi/Aventis Other, Advisory Board. OSE Immunotherapies Other, Data Safety Monitoring Board. AstraZeneca, Merck Other, Investigator Sponsored Trial. T. L. Cannon, Astra Zeneca Independent Contractor, Other, consultant one time. Revolution Medicine Independent Contractor, Other, consultant one time. J. T. Moyers, None.. J. Tu, None. M. Akce, Partner Therapeutics Other, Consulting or advisory role. BMS Other, Consulting or advisory role and Research support to institution. Daichii Sankyo Other, Consulting or advisory role. Taiho Other, Consulting or advisory role. Incyte Other, Consulting or advisory role. Genentech Other, Consulting or advisory role and Research support to institution. AstraZeneca Other, Consulting or advisory role and Research support to institution. Curio Science Other, Consulting or advisory role. GSK Other, Consulting or advisory role. ProDa BioTech Other, Research support to institution. A. Gregory, Pfizer Other, Employment of Immediate Family Member Stock options held by Immediate Family Member. D. C. Hinshaw, None.. G. N. Grantham, None. S. Halabi, BMS Other, Member of DSMB. CG Oncology Other, Member of DSMB. Janssen Other, Member of DSMB. Sanofi Other, Member of DSMB. R. L. Schilsky, Clarified Precision Medicine Stock Option, Other, Leadership Position. Leap Therapeutics Stock, Other, Leadership Position. Cellworks Independent Contractor, Stock Option, Other, Consulting/Advisory Role. ZephyrAI Independent Contractor, Other, Consulting/Advisory Role. Flatiron Health Independent Contractor, Other, Consulting or Advisory Role. Toray Industries Other, Honoraria for service on a study for DSMB. AstraZeneca Other, Research Funding to ASCO in support of the TAPUR Study. Bayer Other, Research Funding to ASCO in support of the TAPUR Study. Bristol Myers Squibb Other, Research Funding to ASCO in support of the TAPUR Study. Genentech/Roche Other, Research Funding to ASCO in support of the TAPUR Study. Lilly Other, Research Funding to ASCO in support of the TAPUR Study. Merck Other, Research Funding to ASCO in support of the TAPUR Study. Pfizer Other, Research Funding to ASCO in support of the TAPUR Study. Boehringer Ingelheim Other, Research Funding to ASCO in support of the TAPUR Study. Taiho Oncology Other, Research Funding to ASCO in support of the TAPUR Study. WUGEN, Inc. Other, Honoraria for service as a DSMB Member. AbbVie Other, Honorarium for lecture. Sygnomics Independent Contractor, Other, consulting or advisory role.

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