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Attend this session at the
2019 ASCO Annual Meeting!


Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Session

Time: Sunday June 2, 8:00 AM to 11:00 AM

Location: Hall A

Palbociclib (P) in patients (pts) with non-small cell lung cancer (NSCLC) with CDKN2A alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2019 ASCO Annual Meeting

Abstract No:
9041

Poster Board Number:
Poster Session (Board #364)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 9041)

Author(s): Eugene R Ahn, Pam K. Mangat, Elizabeth Garrett-Mayer, Susan Halabi, Elie G. Dib, Daniel Ernest Haggstrom, Kathryn B. Alguire, Ricardo H. Alvarez, Carmen Julia Calfa, Timothy Lewis Cannon, Pamela A. Crilley, Anu G. Gaba, Alissa S. Marr, Ashish Sangal, Ramya Thota, Kaitlyn R. Antonelli, Samiha Islam, Andrew Lawrence Rygiel, Suanna S. Bruinooge, Richard L. Schilsky; Cancer Treatment Centers of America, Zion, IL; American Society of Clinical Oncology, Alexandria, VA; Medical University of South Carolina, Charleston, SC; Duke University Medical Center, Durham, NC; Sanford Health, Sioux Falls, SD; Levine Cancer Institute, Charlotte, NC; Grand Rapids Oncology Program, Grand Rapids, MI; Cancer Treatment Centers of America, Newnan, GA; Memorial Cancer Institute, Hollywood, FL; Inova Schar Cancer Institute, Fairfax, VA; Cancer Treatment Centers of America, Boca Raton, FL; Roger Maris Cancer Ctr, Fargo, ND; University of Nebraska Medical Center, Omaha, NE; Cancer Treatment Centers of America, Goodyear, AZ; Intermountain Healthcare, Murray, UT

Abstract Disclosures

Abstract:

Background: TAPUR is a phase II basket study evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Results in a cohort of NSCLC pts with CDKN2A loss or mutation treated with P are reported. Methods: Eligible pts had advanced NSCLC, no standard treatment options, measurable disease, ECOG PS 0-2 and adequate organ function. Genomic testing was performed using commercially available tests. Pts matched to P had NSCLC with CDKN2A loss or mutation and no RB mutations. A Simon two-stage design was used to test a null rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 have disease control (DC) (objective response (OR) or stable disease at 16 weeks (wks) (SD16+)), an additional 18 pts are enrolled. If ≥7 of 28 pts have DC, the drug is considered worthy of further study. Secondary endpoints are progression-free survival (PFS), overall survival (OS) and safety. Results: Twenty-nine pts were enrolled from January 2017 to June 2018; 1 pt was unevaluable for response but is included in safety analyses. Pts received P at 125 mg orally once daily for 21 days, followed by 7 days off. Demographics and outcomes are summarized in Table (N = 28). One PR and 6 SD16+ were observed for a DC rate of 29% (90% CI, 15% to 37%). 10 pts had at least one grade 3 or 4 AE or SAE at least possibly related to P with the most common being cytopenias. Other grade 3-4 AEs or SAEs at least possibly related to P included fatigue, anorexia, febrile neutropenia, myocardial infarction, sepsis, vomiting, and hypophosphatemia. Conclusions: Monotherapy with P demonstrated evidence of anti-tumor activity in heavily pre-treated NSCLC pts with CDKN2A loss or mutation. Additional study is warranted to confirm the efficacy of P in pts with NSCLC with CDKN2A loss or mutation. Clinical trial information: NCT02693535

DC rate, % (OR or SD16+) (90% CI)29% (15%, 37%)
Median PFS, wks (95% CI)7.9 (7.0, 15.1)
Median OS, wks (95% CI)20.6 (14.0, 39.0)
Drug-related AEs, grades 3-4 (% of pts)34%
Drug-related SAEs (% of pts)17%
Median age, yrs (range)63 (41, 79)
Male, %54%
ECOG Performance Status, %
018%
164%
218%
Prior systemic regimens, %
04%
1-225%
≥371%

 
Other Abstracts in this Sub-Category:

 

1. Association of STK11/LKB1 genomic alterations with lack of benefit from the addition of pembrolizumab to platinum doublet chemotherapy in non-squamous non-small cell lung cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 102 First Author: Ferdinandos Skoulidis
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

2. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 110 First Author: Sean Khozin
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

3. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9000 First Author: Kazuhiko Nakagawa
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

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