HAYWARD, Calif. - Arcus Biosciences, Inc. (NYSE:RCUS) revealed clinical study results indicating that its combination therapy of domvanalimab and zimberelimab improves survival rates in non-small cell lung cancer (NSCLC) patients compared to zimberelimab alone or chemotherapy. The data, derived from Part 1 of the ARC-10 study, showed a 36% reduction in the risk of death for patients treated with the combination therapy.
The study, which evaluated the efficacy of the combination therapy in patients with locally advanced or metastatic squamous or non-squamous NSCLC, found that the median overall survival for the domvanalimab plus zimberelimab group was not reached, suggesting it may exceed two years. In contrast, zimberelimab alone reached a median overall survival of 24.4 months.
Treatment-related adverse events leading to discontinuation were lower in the combination therapy group at 10.5%, compared to 23.5% for chemotherapy. The findings will be presented at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting on November 8.
Arcus Biosciences, in partnership with Gilead Sciences (NASDAQ:GILD), conducted the randomized, open-label, three-arm study. The primary endpoint was progression-free survival, with secondary endpoints including overall survival, confirmed objective response rate, and safety.
Domvanalimab, an Fc-silent anti-TIGIT monoclonal antibody, and zimberelimab, an anti-PD-1 monoclonal antibody, are part of Arcus's investigational therapies designed to enhance the immune system's ability to fight cancer. The combination aims to co-inhibit TIGIT and PD-1 pathways, potentially offering greater therapeutic benefit.
As of the data cutoff on May 17, 2024, 95 patients had received treatment, with a median follow-up of 24.5 months. The study found that the 12-month survival rate was 68% for the combination therapy, compared to 57% for zimberelimab alone and 50% for chemotherapy.
The company will discuss these results during its earnings call on Wednesday at 2:00 PM PT / 5:00 PM ET. While the results are promising, it is important to note that domvanalimab and zimberelimab are still investigational drugs and have not received regulatory approval for commercial use.
This article is based on a press release statement from Arcus Biosciences.
In other recent news, Arcus Biosciences announced a strategic partnership with AstraZeneca (NASDAQ:AZN), which is expected to aid in the development of its novel bispecific antibody, Volrustomig. The company also reported a strong Q1 2024 financial performance with GAAP revenue of $145 million, exceeding consensus estimates, and cash reserves of $1.1 billion, largely driven by an $11 million increase in collaboration revenues. Citi has maintained its Buy rating on Arcus Biosciences and increased the price target to $46, reflecting a positive outlook on the company's cancer treatment, cas. BofA Securities, however, maintained a Neutral rating with a price target of $22.00, citing early-stage data on casdatifan as potential challenges. H.C. Wainwright initiated coverage with a Neutral rating and a price target of $20.00, expressing caution about upcoming data releases for the company's drug candidates. Despite a pause on Roche's Phase 2/3 SKYSCRAPER-06 study, Cantor Fitzgerald maintained an Overweight rating on Arcus Biosciences, indicating a shift in focus from non-small cell lung cancer to upper gastrointestinal cancers.
InvestingPro Insights
Arcus Biosciences' promising clinical results for its combination therapy in NSCLC patients are reflected in some of the company's financial metrics. According to InvestingPro data, Arcus has shown impressive revenue growth, with a 104.13% increase over the last twelve months as of Q2 2024. This growth aligns with the potential market impact of their innovative cancer treatments.
However, investors should note that Arcus is currently not profitable, with a negative gross profit margin of -38.46% over the same period. This is not uncommon for biotech companies investing heavily in research and development. An InvestingPro Tip highlights that Arcus is "quickly burning through cash," which is typical for companies in the clinical trial phase of drug development.
On a positive note, another InvestingPro Tip indicates that Arcus "holds more cash than debt on its balance sheet," suggesting financial stability as they progress through clinical trials. This could be crucial for supporting ongoing research and potential commercialization of their promising therapies.
For investors seeking a deeper understanding of Arcus Biosciences' financial health and prospects, InvestingPro offers 9 additional tips, providing a more comprehensive analysis of the company's position in the competitive biotech landscape.
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