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Gilead (GILD), RCUS Announce Positive Data From NSCLC Study

Gilead Sciences, Inc. GILD and partner Arcus Biosciences RCUS announced a positive update from the fourth interim analysis of the mid-stage study, ARC-2, in patients with first-line metastatic non-small cell lung cancer (NSCLC). Shares of RCUS were up 7.2% on the update.

The ARC-7 study is a phase II, multicenter, 3-arm, randomized open-label study evaluating the safety and efficacy of anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab (doublet) compared to domvanalimab plus zimberelimab and etrumadenant (triplet), an A2a/b adenosine receptor antagonist, versus zimberelimab alone in 150 patients with first-line metastatic NSCLC with PD-L1 TPS ≥50% and no epidermal growth factor receptor or anaplastic lymphoma kinase (EGFR/ALK) mutations.

Per the protocol, this analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of Aug 31, 2022. A total of 150 patients have been randomized across the three study arms. Efficacy was evaluated in study patients who had at least 13 weeks of potential follow-up and were eligible for at least two imaging scans (n=133) for this analysis.

Results showed that combining two checkpoint inhibitors – an anti-TIGIT and an anti-PD-1 – delivered added benefit beyond anti-PD-1 monotherapy in this setting, as both domvanalimab combinations continued to show clinically meaningful differentiation compared to zimberelimab monotherapy across multiple efficacy measures, including objective response rates (ORR), progression-free survival (PFS) and six-month landmark PFS.

No unexpected safety signals were observed across the three-study arm at the time of data cutoff.

The three-phase III domvanalimab combination studies in NSCLC are ongoing.

We note that Gilead entered into an option, license and collaboration agreement with Arcus in 2020, thereby obtaining the right to opt in to all current and future clinical-stage product candidates (rights to zimberelimab, as well as the right to opt-in to all other current Arcus clinical candidates, which include AB154, AB928 and AB680) for up to 10 years following the closing of the transaction.

Shares of Gilead have gained 20.7% so far this year against the industry’s decline of 24.9%.

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Gilead is geared up to expand beyond antivirals into other therapeutic areas such as oncology. While its legacy HIV business maintains momentum on flagship HIV therapy, Biktarvy, Gilead is looking to add more arms to its arsenal.

Gilead’s Cell Therapy franchise, comprising Yescarta and Tecartus, is gradually and steadily gaining traction. The uptake of the breast cancer drug Trodelvy has been strong and has boosted the top line.

The oncology space is lucrative and Gilead can capitalize on it, thereby creating a revenue growth driver in addition to the HIV franchise.

Gilead currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the healthcare sector include Biogen BIIB and Solid Biosciences SLDB, which carry the same rank as Gilead. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 30 days, earnings estimates for Biogen have increased by 30 cents to $16.98. Biogen also surpassed estimates in three of the trailing four quarters, with the average being 7.02%.

Over the past 30 days, loss estimates for Solid Biosciences have narrowed to $8.04 from $10.15. SLDB missed estimates in three of the trailing four quarters, with the average negative surprise being 4.15%.

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