Dr. Luis Paz-Ares on the Phase 3 EVOKE-01 Study

Luis Paz-Ares, MD, PhD, of Hospital Universitario 12 de Octubre, discusses his 2024 American Society of Clinical Oncology Annual Meeting presentation on the primary analysis of the open-label, phase 3 EVOKE-01 study.

The study compared sacituzumab govitecan with standard-of-care docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, anti–PD-L1, and targeted treatment for actionable genomic alterations. The intention-to-treat population included 299 patients receiving sacituzumab govitecan and 304 receiving docetaxel.

“The main end point of the trial was overall survival (OS), and some other relevant secondary end points included here were concerning efficacy, safety, and tolerability, but also quality of life,” Dr. Paz-Ares said.

There was a numerical improvement in OS with sacituzumab govitecan (median OS, 11.1 months) compared with docetaxel (median OS, 9.8 months). However, it was not statistically significant (hazard ratio, 0.84 [95% CI, 0.68-1.04]; one-sided P=.0534), and the OS end point was not met.

Dr. Paz-Ares shared his insights on patient subgroups and how different disease features may have affected patient responses to the treatments.

“Some analysis of the trial previously planned suggested that those patients [who] did not respond to PD-1 or PD-L1–containing blocker regimens were actually benefiting more from [sacituzumab govitecan] as compared [with] those patients [who did] respond to PD-1 or PD-L1–containing regimens [who] did not respond, [who] did not benefit at all from [sacituzumab govitecan],” he said. “And indeed, even the number of patients with actionable genomic aberration was very small, 44 patients. Those patients maybe also derive a greater benefit as compared [with] the patients without actionable genomic aberrations.”

Dr. Paz-Ares also spoke about the safety results observed in the EVOKE-01 trial.

“I would say that [sacituzumab govitecan] was a bit better tolerated, with [fewer] patients requiring treatment discontinuation, 10% as compared [with] 17%,” he said.

Dr. Paz-Ares concluded by touching on some of the questions that remain in terms of using antibody-drug conjugates (ADC) to treat lung cancer and directions for future research.

“It would be nice, at the end of the day, to have specific factors that help us decide which patient is going to benefit from each specific ADC and which patient is not going to benefit at all from a given drug,” he said.