Yahoo Finance Gilead (GILD), RCUS Announce Data From Colorectal Cancer Study
Gilead Sciences, Inc. GILD and partner Arcus Biosciences, Inc. RCUS announce new data from Cohort B of the ARC-9 study.
ARC-9 is a phase Ib/II study evaluating the safety and efficacy of etrumadenant (E), a dual A2a/A2b adenosine receptor antagonist, plus anti-PD-1 antibody zimberelimab (Z), FOLFOX and bevacizumab (“EZFB”), in three cohorts of patients suffering from metastatic colorectal cancer (mCRC).
Cohort B of ARC-9 randomized 112 patients with comparable baseline characteristics between two arms: EZFB and regorafenib.
Etrumadenant is an investigational small molecule, selective dual antagonist of the A2a and A2b receptors designed to prevent adenosine-mediated immunosuppression. Arcus’ zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody.
EZFB significantly reduced the risk of death by 63% and the risk of disease progression by 73% compared to regorafenib. The median follow-up was 20.4 months at the time of data cut-off (Nov 13, 2023). The median overall survival (OS) was 19.7 months for EZFB and 9.5 months for regorafenib.
The median progression-free survival (PFS) was 6.2 months for EZFB and 2.1 months for regorafenib. The objective response rate (ORR) was 17.3% for EZFB and 2.7% for regorafenib.
A higher percentage of patients treated with regorafenib (17%) had a treatment emergent adverse event leading to discontinuation of all study drugs than those treated with EZFB (5%).
The results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Both companies also announced long-term efficacy and safety results from Arm A1 of the phase II EDGE-Gastric study.
The ongoing, multi-arm, global EDGE-Gastric study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab, plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in this patient population.
These updated data show consistent ORR and provide mature PFS in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma (upper GI cancers).
Roughly 60% of patients in the EDGE-Gastric study achieved PFS at 12 months. The encouraging data support the ongoing phase III STAR-221 Study of domvanalimab, plus zimberelimab and chemotherapy.
With a median time on treatment of 49.4 weeks, the domvanalimab plus zimberelimab and chemotherapy regimen demonstrated sustained improvement across efficacy measures, including patients with low PD-L1 expression.
In the year-to-date period, shares of Gilead have lost 20.4% compared with the industry’s decline of 6.6%.
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GlLD and RCUS expanded their collaboration agreement in 2023 to include therapies for the treatment of inflammatory diseases. The collaboration earlier focused on oncology.
Gilead is looking to diversify its portfolio beyond the legacy HIV franchise into oncology and inflammation.
However, last week, the company announced the failure of its late-stage confirmatory TROPiCS-04 study on Trodelvy in locally advanced or metastatic urothelial cancer (mUC).
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. It is approved in several countries for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies.
The top-line results showed that the study did not meet the primary endpoint of OS in the intention-to-treat population. Additionally, there was a higher number of death due to adverse events with Trodelvy compared to TPC in the overall study population. These adverse events, mostly observed in the early phase of the treatment course, were related to neutropenic complications.
In January 2024, Gilead suffered another setback when the phase III EVOKE-01 study on Trodelvy did not meet its primary endpoint of OS in previously treated metastatic non-small cell lung cancer.
Zacks Rank & Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks from the healthcare sector are ALX Oncology Holdings ALXO and Krystal Biotech KRYS, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for KRYS’ earnings per share has increased 24 cents to $2.06. KRYS beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 21.46%. Shares of Krystal Biotech have surged 33.3% year to date.
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