Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences announced that the European Medicines Agency's CHMP has issued a positive opinion for lenacapavir, an investigational treatment for HIV-1 infection in adults with multi-drug resistance. This recommendation, based on Week 26 data from the CAPELLA trial, supports lenacapavir as a twice-yearly treatment option for patients with limited options. In the trial, 81% of participants achieved viral suppression, with lenacapavir showing good tolerability. The final decision from the European Commission is anticipated later this year.

Gilead Sciences has released Week 48 results from its pivotal Phase 3 trial assessing Hepcludex (bulevirtide) for chronic hepatitis delta virus (HDV). The data demonstrate significant viral declines and improved patient-reported outcomes (PROs). At Week 48, 45% and 48% of patients treated with bulevirtide achieved combined virological and biochemical responses, compared to only 2% in the untreated group. The treatment's safety profile remains consistent, with no serious adverse events. The findings were presented at the International Liver Congress 2022, reinforcing bulevirtide's potential as a therapeutic option for this high-burden disease.

Gilead Sciences (Nasdaq:GILD) announced over 80 abstracts will be presented at the International Liver Congress™ (ILC) 2022 from June 22-26, 2022. Key highlights include Phase 3 data on Hepcludex (bulevirtide) for treating hepatitis delta virus (HDV), focusing on efficacy and patient-reported outcomes. Presentations will also cover hepatitis C (HCV) elimination efforts, chronic hepatitis B (HBV) treatments, and research in nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). Bulevirtide has received Conditional Marketing Authorization in Europe and is under FDA review in the U.S.

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.