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CLAIM #27063 · GILD (GILD) · 2024Q1 earnings call · Apr 25, 2024 · due Dec 31, 2024

In TNBC, where Trodelvy is the only ADC to have demonstrated statistically significant improvement in overall survival in the second-line setting, we expect to share an update on the Phase III ASCENT-03 trial in first-line PD-L1 negative patients later this year.

Merdad Parsey · Chief Medical Officer

PENDING
graded after results covering Dec 31, 2024 are reported

In context

second-line plus metastatic non-small cell lung cancer trial, EVOKE-01. Updated data from first-line, PD-L1 high subjects in Cohort A of the Phase III EVOKE-02 trial will also be shared. We plan on providing updates from Cohorts C and D, evaluating Trodelvy plus pembro and chemotherapy in PD-L1 all-comers at a medical congress in the second half of this year. In addition, presentations for both the Phase III EDGE-Gastric trial and Phase III ARC-9 studies will be highlighted. Depending on the timing of event accruals, we anticipate 2 more Phase III updates this year for Trodelvy. These include overall survival data from our confirmatory Phase 3 bladder cancer study, TROPiCS-04, that could support Trodelvy’s submission for full regulatory approval in the U.S. and enable ex-U.S. filings. In TNBC, where Trodelvy is the only ADC to have demonstrated statistically significant improvement in overall survival in the second-line setting, we expect to share an update on the Phase III ASCENT-03 trial in first-line PD-L1 negative patients later this year. Moving on to Cell Therapy. I’'m pleased to share Kite's approach to the development of novel cell therapies that Cindy and the team presented at last month’'s investor event. As you can see on slide 19 Yescarta and Tecartus established Kite as the leader in Cell Therapy, and we plan to potentially extend this leadership into multiple myeloma, while also paving the way for innovative next-generation constructs. On anito-cel in later-line multiple myeloma, we expect to provide a Phase III iMMagine-1 trial update in the second half of this year. This update follows the highly encouraging Phase I data presented at ASH last year, where anito-cel demonstrated durable responses with median progression-free survival not yet met at 26.5 months median follow-up –and no cases of parkinsonian sym

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SEC filings for GILD · Claim quote is verbatim from the 2024Q1 earnings call.