CLAIM #27015 · GILD (GILD) · 2023Q4 earnings call · Feb 6, 2024 · due Dec 31, 2024
“For now, given these findings, we currently do not plan changes to our Phase 3 EVOKE-03 study that is enrolling as expected.”
Merdad Parsey · Chief Medical Officer
In context
“sease or progressive disease as their best outcome to last prior I/O therapy, and represented more than 60% of the trial population. This analysis was not alpha-controlled for formal statistical testing, and we are continuing to analyze these data. We will discuss these data with regulators and KOLs to determine the best path forward. As a reminder, we required all patients to have received prior I/O therapy, regardless of driver mutation status, and responsiveness to prior I/O was a stratification factor. Additional analyses, including TROP2 expression, are ongoing and we will share these data as quickly as possible. Based on these observations and the data from the ongoing EVOKE-02 study, we remain confident in Trodelvy’s potential in patients with metastatic non-small cell lung cancer. For now, given these findings, we currently do not plan changes to our Phase 3 EVOKE-03 study that is enrolling as expected. Moving to Slide 20, our novel twice-daily, oral antiviral, obeldesivir, did not demonstrate statistically significant symptom relief in standard-risk, non-hospitalized patients with COVID-19 in our Phase 3 OAKTREE trial. Obeldesivir was well-tolerated in this large study population, and we will share the data at a future medical meeting. Overall, the OAKTREE results reflect the decreasing severity and duration of COVID-19 symptoms observed in standard-risk patients, driven by the evolution of variants and improved immunity to COVID-19 in our trial population. The time to symptom alleviation in untreated, standard-risk patients is now less than a week, as compared to almost two weeks at the peak of the pandemic. As a result, it was challenging for obeldesivir to show a benefit in the stand”
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SEC filings for GILD ↗ · Claim quote is verbatim from the 2023Q4 earnings call.