Gilead Sciences Inc Stock Price, News & Analysis

Trodelvy, developed by Gilead Sciences, demonstrated significant benefits in the Phase 3 ASCENT study for patients with relapsed metastatic triple-negative breast cancer (TNBC). The data revealed a median progression-free survival of 4.8 months compared to 1.7 months with chemotherapy (HR: 0.41; p<0.0001) and an overall survival of 11.8 months vs 6.9 months (HR: 0.51; p<0.0001). Additionally, Trodelvy improved health-related quality of life across five domains. The safety profile was consistent with previous reports, with manageable adverse reactions.

Kite, a Gilead Company (GILD), presented three-year follow-up results from the ZUMA-2 trial for Tecartus in relapsed/refractory mantle cell lymphoma (MCL) showing an overall response rate (ORR) of 91% and median overall survival (OS) of 46.6 months. In the ZUMA-3 trial for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), the two-year follow-up revealed a CR rate of 73.1% with a median OS of 25.4 months. Both trials demonstrated long-term efficacy, with Tecartus being the only CAR T-cell therapy approved for these indications.

Kite, a Gilead Company (GILD), announced promising results from the ZUMA-7 trial of Yescarta for treating large B-cell lymphoma (LBCL) in patients aged 65 and older. The trial showed Yescarta significantly outperformed standard of care (SOC) in two-year event-free survival (EFS) rates, achieving over three-fold higher in elderly patients. Median EFS was also markedly better at 21.5 months versus 2.5 months for SOC. Quality of life improvements were noted, alongside manageable safety profiles. The FDA recently expanded Yescarta's approval as an initial treatment for refractory LBCL.

Everest Medicines' licensing partner, Gilead Sciences (GILD), reported promising results from the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2- metastatic breast cancer patients. The study achieved its primary endpoint of progression-free survival, showing a 34% reduction in the risk of disease progression or death (median PFS: 5.5 months vs. 4 months). Notably, 21% of patients treated with Trodelvy remained progression-free at the one-year mark, compared to 7% in the chemotherapy group. Trodelvy's safety profile was consistent with previous studies, indicating no new safety concerns.

Gilead Sciences announced positive results from the Phase 3 TROPiCS-02 study for Trodelvy in treating HR+/HER2- metastatic breast cancer. The study showed a 34% reduction in disease progression risk (median PFS: 5.5 vs. 4 months). At one year, 21% of Trodelvy patients were progression-free, compared to 7% for chemotherapy. A positive trend in overall survival was noted. The quality of life analysis indicated Trodelvy improved global health status and fatigue. No new safety issues emerged, although neutropenia and diarrhea were common. Trodelvy awaits regulatory approval for this indication.

Kite, a Gilead Company (GILD), announced findings from the largest real-world analysis of CAR T-cell therapy, Yescarta, focusing on racial and ethnic differences in outcomes for patients with relapsed or refractory large B-cell lymphoma (LBCL). The study revealed that Black or African American patients had longer times from diagnosis to treatment compared to White patients, potentially affecting response rates. Overall, Yescarta showed consistent efficacy across races. Findings were presented at the 2022 ASCO Annual Meeting, highlighting a need for further research on equity in CAR T-cell therapy access.

Gilead Sciences, Inc. has appointed Dr. Stacey Ma as the new Executive Vice President for Pharmaceutical Development and Manufacturing, effective July 18, 2022. She succeeds Dr. Taiyin Yang, who is retiring after 29 years with the company. Dr. Ma has over 25 years of experience in pharmaceutical development and manufacturing, previously serving as Executive Vice President at Sana Biotechnology. Gilead's CEO, Daniel O'Day, expressed confidence in Dr. Ma's leadership to maintain excellence in drug development and manufacturing during a time of portfolio diversification.

Gilead Sciences (Nasdaq: GILD) and Kite will present over 20 abstracts at the 2022 ASCO Annual Meeting, including groundbreaking findings in breast and blood cancers. Notable studies include the TROPiCS-02 trial for HR+/HER2- breast cancer and analyses from the ZUMA-7 CAR T-cell therapy trial, highlighting treatment options for older patients. Additionally, data on MDS and AML treatment advancements will be showcased. These presentations underscore Gilead's commitment to addressing critical gaps in oncology care.