Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
Sunlenca (lenacapavir) has received FDA approval as the first capsid inhibitor for HIV-1 treatment in adults experiencing multi-drug resistant HIV infections. This drug, distinguished by its unique multi-stage action, offers a twice-yearly treatment option, addressing a critical gap for patients with limited therapy choices. The approval is based on the CAPELLA trial, which demonstrated an 83% success rate in achieving undetectable viral loads at Week 52. Sunlenca’s long-acting properties and broad application potential mark it as a significant advancement in HIV treatment.
Gilead Sciences supports the Transinclusive Group, led by Tatiana Williams, a Black-led advocacy group aimed at improving resources for Trans individuals in Florida. The group has launched a peer-run housing program called CHOICES, funded by a Gilead TRANScend grant, which offers transitional housing along with healthcare, job training, and financial advice. Despite its success, the program faces challenges with increasing demand and limited capacity. The initiative focuses on fostering community resilience among Trans individuals.
Gilead's Kite has announced the acquisition of Tmunity Therapeutics, enhancing its CAR T-therapy capabilities. This strategic move will add pipeline assets and access to innovative research through a partnership with the University of Pennsylvania. Tmunity's armored CAR T technology may improve anti-tumor activity, and Kite will now manage ongoing research collaborations with Penn. The financial terms remain undisclosed, but the deal is forecast to reduce Gilead's 2023 EPS by approximately $0.18-$0.22. The acquisition is expected to close in Q1 2023, pending regulatory approvals.
Gilead Sciences (GILD) and Arcus Biosciences (RCUS) reported positive interim results from the ARC-7 study, a Phase 2 trial in patients with first-line metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. Both doublet and triplet therapy arms containing domvanalimab showed a 35-45% reduction in the risk of progression or death compared to zimberelimab monotherapy, with median progression-free survival (PFS) of 12.0 months for the doublet and 10.9 months for the triplet. Results will be showcased on December 20 during the ASCO Monthly Plenary Series.
Gilead Sciences and Arcus Biosciences reported promising results from the ARC-7 Study, focusing on first-line, metastatic non-small cell lung cancer (NSCLC). The study demonstrated a 35-45% reduction in the risk of progression or death and a significant improvement in median progression-free survival (PFS) with the combination therapies compared to zimberelimab monotherapy. The objective response rates showed a positive trend, with the doublet and triplet arms showing 41% and 40%, respectively. Further detailed results will be presented on December 20.
Gilead Sciences has announced its support for Latinas Contra Cancer, a nonprofit focused on advocating for improved cancer care in the Latinx community. Executive Director Darcie Green highlights the challenges faced in navigating healthcare systems, drawing from her personal experience. The organization has launched the Defensoras: Healthcare Advocate Training program, empowering cancer patients to advocate for their rights. This initiative aims to address racial and ethnic disparities in healthcare, ultimately enhancing patient knowledge and support.
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Kite, a Gilead Company (Nasdaq: GILD), presented follow-up analyses from pivotal studies ZUMA-2 and ZUMA-3 on CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and mantle cell lymphoma (MCL). Findings revealed significant overall survival advantages, with Tecartus showing improved two-year outcomes compared to standard care. Tecartus is the first CAR T-cell therapy approved for adults with these conditions. Presentations took place at the 2022 ASH Annual Meeting on December 10 and 12.
Kite, a Gilead Company (Nasdaq: GILD), announced significant three-year follow-up data from the ZUMA-5 study for Yescarta (axicabtagene ciloleucel), showing sustained response in 52% of patients with relapsed or refractory indolent non-Hodgkin lymphoma. The study reported an overall response rate (ORR) of 90% and a complete response (CR) rate of 75% among 159 patients. Additionally, ZUMA-1 data highlighted the benefits of prophylactic corticosteroids in managing patient safety without compromising treatment outcomes. Yescarta remains a pivotal therapy in treating difficult lymphomas.
Kite, a Gilead Company (Nasdaq: GILD), announced outcomes from two analyses of the ZUMA-7 trial for Yescarta, a CAR T-cell therapy for relapsed or refractory large B-cell lymphoma (r/r LBCL). Findings reveal 47% of patients needing subsequent therapy after second-line Yescarta compared to 71% for standard care. The study affirmed Yescarta's superiority in event-free survival (EFS) and progression-free survival (PFS), particularly for patients with varying metabolic tumor volumes. Yescarta's FDA approval in April 2022 and EMA's in October 2022 continue to underline its pivotal role in lymphoma treatment.