Late-Breaking Abstracts at ESMO Could Potentially Change Lung Cancer Practice

Lyudmila A. Bazhenova, MD

The 2017 ESMO Annual Congress, taking place September 8 to 12 in Madrid, Spain, will feature several late-breaking abstracts that are poised to change the future of treatment for patients with lung cancer, pending their results. Saturday’s Presidential Symposium, which is focused on lung cancer, will include presentations on the results of the phase III PACIFIC and FLAURA studies—both of which could change the current standard-of-care treatment in the field if positive.

The pivotal phase III PACIFIC trial explored the efficacy of durvalumab (Imfinzi) in patients with locally advanced, stage III unresectable non—small cell lung cancer (NSCLC) following standard chemoradiation therapy. Though the data have not yet been released, AstraZeneca, the developer of the agent, announced in May 2017 that the randomized, double-blind, placebo-controlled, multicenter trial had met its primary endpoint by showing statistically significant and clinically meaningful progression-free survival (PFS) in these patients.

Based on these interim results, durvalumab was granted breakthrough therapy designation by the FDA this past July. The agent has already received accelerated approval in previously treated patients with advanced bladder cancer.

Another highly anticipated presentation is the results of the phase III, double-blind, randomized FLAURA study, which assessed the efficacy and safety of osimertinib (Tagrisso) versus the current standard of care treatment of erlotinib (Tarceva) or gefitinib (Iressa) in previously untreated patients with locally advanced or metastaticEGFR-mutant NSCLC. Though the data have not yet been released, AstraZeneca, which is also the developer of the third-generation EGFR inhibitor, announced in July that osimertinib showed a statistically significant and clinically meaningful PFS benefit over the current standard-of-care treatment.

Currently, there are 3 agents approved by the FDA for frontlineEGFR-mutant NSCLC—erlotinib, gefitinib, and afatinib (Gilotrif)—which each have similar efficacy and varying toxicity profiles. None of these agents have shown a superior overall survival (OS) benefit; therefore, the OS findings of the FLAURA trial will be crucial.

“Depending on the results, these studies might change the standard of care,” said Lyudmila A. Bazhenova, MD, a medical oncologist and professor of medicine at UC San Diego Health.

Another late-breaking abstract at this year’s meeting, which will be presented by Bazhenova, is a phase Ib study of RXDX-105, a VEGFR-sparing potent RET inhibitor, in patients withRETfusion-positive NSCLC. This is a first-in-human, multicenter, open-label study consisting of 2 phases. The phase Ib portion is a dose expansion in approximately 90 patients with advanced solid tumors harboring aRETorBRAFrearrangement or mutation. Bazhenova will be reporting the efficacy of the drug in a cohort of patients with NSCLC.

“Currently, there are no approved drugs forRET