1314P - Patient-reported outcomes (PROs) from the phase III EVOKE-01 trial of sacituzumab govitecan (SG) vs docetaxel (doc) in metastatic non-small cell lung cancer (mNSCLC)

Background

Although EVOKE-01 study did not meet the primary endpoint, there was a trend towards overall survival improvement over doc in patients (pts) with mNSCLC previously treated with platinum-based chemotherapy and PD(L)-1 inhibitors. Here, we report results from prespecified secondary and exploratory PRO endpoints.

Methods

Pts were randomized to receive SG (10 mg/kg IV, days 1 and 8) or doc (75 mg/m² IV, day 1) in 21-day cycles until progression or unacceptable toxicity. Pts completed the NSCLC Symptom Assessment Questionnaire (SAQ) and the EORTC QLQ-C30 prior to treatment (tx) each cycle. Time to first meaningful deterioration or death (TTD) from baseline (BL) on the PROs was assessed in the intent-to-treat population and compared between tx using stratified Cox regression models, with the NSCLC-SAQ shortness of breath domain and total scores pre-specified as key secondary endpoints. Changes from BL at Week 25 were assessed between tx using linear mixed effect models.

Results

This analysis included 603 pts (299 SG, 304 doc; median age 66 y). PRO compliance rates were high (>85%) for most visits and both tx arms. In most domains, SG demonstrated longer TTD vs doc (fatigue, shortness of breath, and total score [NSCLC-SAQ] and fatigue and dyspnea [QLQ-C30] [P-values <0.05; Table]). Least squares mean change favored SG in these domains at Week 25 (P-values <0.01; Table). Higher deterioration rates in tx-related side effects (diarrhea and nausea/vomiting) were observed with SG.

Conclusions

SG delayed deterioration and reduced symptom burden in key NSCLC-related symptoms compared to doc. There was an expected worsening of symptoms related to the known safety profile of SG. These data further support the clinical observation that SG is an active agent in the treatment of mNSCLC. Table: 1314P

TTD and difference in least square mean changes from baseline at week 25 in SG vs Doc

Note: HR < 1 and differences in least square mean change < 0 are in favor of SG.*P-value

Clinical trial identification

NCT05089734.

Editorial acknowledgement

Legal entity responsible for the study

Gilead Sciences, Inc.

Funding

Gilead Sciences, Inc.

Disclosure

N. Reinmuth: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, GSK, F. Hoffmann-La Roche, Lilly, Merck, MSD, Pfizer, Sanofi, Takeda; Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, MSD. L.G. 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