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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

A phase 1/2 study of osimertinib and bevacizumab as initial treatment for patients with metastatic EGFR-mutant lung cancers.

Metastatic Non-Small Cell Lung Cancer

Lung Cancer—Non-Small Cell Metastatic

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #409)

J Clin Oncol 37, 2019 (suppl; abstr 9086)

Author(s): Helena Alexandra Yu, Rachel Kim, Alex Makhnin, Linda Su Hyun Ahn, Ai Ni, Sara A. Hayes, Robert J. Young, Gregory J. Riely, Mark G. Kris; Memorial Sloan Kettering Cancer Center, New York, NY; Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY

Abstract Disclosures


Background: Osimertinib (osi) demonstrated improved progression-free survival (PFS) over erlotinib as initial treatment (trmt) for EGFR-mutant (EGFR+) lung cancers. The addition of bevacizumab (bev) to erlotinib as initial trmt resulted in improved PFS compared to erlotinib alone (16 vs 10 months, HR 0.41). The phase 1 study of osi and bev confirmed the ability to combine osi and bev at full doses. Methods: The phase 2 study is assessing safety and efficacy of the combination. The primary endpoint is PFS at 12 months; secondary endpoints include overall response (ORR), overall survival (OS), and CNS PFS. All pts had interval CNS as well as systemic imaging. Pre-treatment and post-progression (PD) tumor tissue and interval plasma samples are being collected to identify mechanisms of resistance (MOR) and for biomarker assessment. Results: From Nov 2016 to May 2018, 49 pts were enrolled, including 6 pts from the phase 1. Median age: 60; Women 69%; Never-smokers 65%. 13 pts had CNS metastases (9 untreated, 5 measurable) prior to study initiation. 49 pts are eligible for response; 34/49 pts had a confirmed partial response (PR)(ORR 69%). PFS at 12 months is 0.70 (95% CI: 0.57-0.84), with 8/49 pts on study without PD for less than 12 months. All pts with measurable CNS disease had a PR in the CNS; PD in the CNS was uncommon (17%). 24 pts remain on study without PD; 2 are being treated beyond PD. Reasons for study discontinuation include PD (n = 16), resection of all sites of disease (n = 3), withdrawal of consent (n = 3), unrelated death (n = 2), toxicity (n = 1). The most frequent trtmt-related adverse events (any grade) were thrombocytopenia (61%), diarrhea (57%), hypertension (55%), and rash (47%). 24% required a dose reduction of osi, 18% discontinued bev and median doses of bev was 17. 9 pts have paired pre-trtmt and post-progression tissue biopsies; MOR identified include squamous cell (n = 2) and small cell (n = 1) transformation, PTEN loss, and CCNE amplification. Conclusions: Combination osi and bev was well-tolerated and efficacy to date supports further evaluation. Results of secondary endpoints including PFS, mechanisms of resistance, cfDNA data are forthcoming. A randomized study of osi compared to osi and bev is planned (EA5182). Supported by AstraZeneca Clinical trial information: NCT02803203

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