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Gilead (GILD), Arcus Announce Results From Mid-Stage NSCLC Study

Gilead Sciences, Inc. GILD and partner Arcus Biosciences, Inc. RCUS announced encouraging updated results from an interim analysis of the mid-stage ARC-7 study in patients with first-line metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.

This phase II randomized, open-label study is evaluating the combinations of Fc-silent anti-TIGIT monoclonal antibody domvanalimab plus anti-PD-1 monoclonal antibody zimberelimab (doublet) and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab monotherapy in 150 patients. ARC-7 is a proof-of-concept study to assess the safety and efficacy of domvanalimab-containing study arms over zimberelimab monotherapy.

Patients in the study were randomized 1:1:1 across the three study arms and patients who progress on zimberelimab monotherapy may cross over to receive the triplet. A median follow-up of 18.5 months at the time of this interim analysis was performed on 150 patients. The co-primary endpoints are objective response rate and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary endpoints include duration of response, disease control rate, overall survival and safety.

As of the data cut off on Feb 7, 2023, safety and efficacy were evaluated in all patients randomized and treated. Both domvanalimab-containing study arms demonstrated sustained, clinically meaningful improvements in PFS compared with zimberelimab monotherapy, with a 33% reduction in risk of disease progression or death for the doublet and 28% for the triplet, with a median follow-up time of approximately 18 months.

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The objective response rate (ORR) improved in both domvanalimab-containing study arms compared with zimberelimab monotherapy.

The results will be presented during the American Society of Clinical Oncology (ASCO) Plenary Series.

In 2020, Gilead and Arcus entered into a 10-year partnership to co-develop and co-commercialize current and future therapeutic product candidates in Arcus’s pipeline.

Last month, both companies expanded their existing research collaboration focused on oncology to include therapies for the treatment of inflammatory diseases.

Domvanalimab is currently being evaluated in four registrational phase III studies across lung and gastrointestinal cancers, including ARC-10, evaluating domvanalimab plus zimberelimab versus pembrolizumab in first-line locally advanced or metastatic PD-L1 ≥50% NSCLC; PACIFIC-8 evaluating domvanalimab plus durvalumab in unresectable Stage 3 NSCLC; STAR-121, evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy in first-line PD-L1-unselected NSCLC; and STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy versus nivolumab plus chemotherapy in first-line locally advanced, unresectable or metastatic gastric, esophageal and gastro-esophageal junction adenocarcinomas.

Shares of Gilead gained 25.2% in the past year against the industry’s decline of 4.9%.

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Gilead is looking to diversify in the lucrative oncology space. The oncology business put up a stellar performance in the first quarter and fueled its top line. The Cell Therapy franchise, comprising Yescarta and Tecartus also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in R/R LBCL as well as Tecartus in R/R ALL and MCL.

The uptake of the breast cancer drug Trodelvy has been strong as well.

Gilead is making efforts to strengthen its pipeline in this space through strategic collaborations. In May 2023, Gilead acquired XinThera, a privately held biotech company in San Diego. The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets in oncology and inflammation.

Earlier it entered into a strategic collaboration with Arcellx, Inc. to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma.

Meanwhile, Gilead has a strong HIV portfolio with Biktarvy and Descovy. Biktarvy remains the leading treatment for those seeking to switch to a new regimen in the United States, as well as those starting treatments in both the United States and Europe.

Zacks Rank and Stocks to Consider

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals LGND and Novartis NVS. LGND currently sports a Zacks Rank #1 and Novartis carries a Zacks Rank #2 (Buy).

Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.

Over the past 60 days, NVS’ earnings estimates have increased to $6.67 from $6.56 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
 


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