Arcus Biosciences, Inc. Q3 FY2023 earnings call

• Domvanalimab Data: Positive Phase 2 data from EDGE Gastric trial for first-line metastatic upper GI adenocarcinomas, ORR for PD-L1 high population exceeded historical benchmarks, 6-month PFS data differentiated, supporting STAR-221 Phase 3 study.
• Pipeline Execution: AB521 HIF-2-alpha inhibitor: early 2024 data from Phase 1b trial, dose escalation close to completion. Quemliclustat CD73 inhibitor: ARC-8 trial in pancreatic cancer with mature OS data expected early 2024, synthetic control data to validate benefit.
• STAR-221 Study: Enrolling well, dual primary endpoints for overall survival in TEP high and ITT populations.
• HIF-2-alpha Program: AB521 has better pharmacokinetics than Belzutepin, Phase 1b expansion cohort enrollment near completion, data on efficacy and safety expected early 2024.
• Pancreatic Cancer Trial: ARC-8 trial in pancreatic cancer with mature OS data (median follow-up 21 months), synthetic control data to validate benefit.

No detailed breakdown of product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

• STAR-221 study enrolling exceptionally well, expected to accelerate recruitment.
• AB521 Phase 1b data (safety, PK, PD, efficacy) in early 2024.
• ARC-8 trial data (ORR, PFS, OS) including synthetic control data early 2024.
• Cash runway expected to fund operations into 2026.
• Phase 3 studies for DOM expected in 2025 plus, but STAR-221 enrolling ahead of schedule.

• Uncertainties in clinical trial outcomes, including event-driven timelines for data maturation.
• Regulatory approval challenges for new therapies.
• Competition from other companies in the oncology space, including potential issues with biomarkers and testing for other therapies.

Q: Yigal Nochomovitz from Citigroup asked about STAR-221 trial design, primary endpoints, and FC silent antibody hypothesis.

A: Dimitry Nuyten and Terry Rosen discussed dual primary endpoints, TAP stratification, and FC silent antibody's impact on safety and efficacy.

Q: Jonathan Miller from Evercore ISI asked about AB521 PK vs Merck compound, and TIGIT trial PFS data.

A: Terry Rosen explained AB521's better pharmacokinetics due to physical chemical properties, and TIGIT trial PFS data expected to mature in second half of 2024.

Q: Robin Karnauskas from Truist asked about waterfall plot, PD-L1 negative responses, and pancreatic trial follow-up.

A: Terry Rosen discussed immune response dynamics with chemo and immunotherapy, and pancreatic trial median OS context.

Q: Kaveri Polman from BTIG asked about TAP vs CPS assessment in PD-L1, and ARC8 synthetic control data.

A: Dimitry Nuyten explained TAP vs CPS concordance and importance of synthetic control data for ARC8.

Q: Mara Goldstein from Mizzou asked about STAR-221 enrollment and timing.

A: Terry Rosen stated STAR-221 is enrolling exceptionally well and accelerating recruitment.

Q: Salveen Richter from Goldman Sachs asked about gastric TIGIT data and positioning TIGIT in the conversation.

A: Jennifer Jarrett discussed TIGIT vs CLADIN 18.2, lower toxicity of TIGIT, and testing challenges for CLADIN 18.2.

Q: Jason Zemanski from Bank of America asked about positioning TIGIT in gastric cancer conversation.

A: Jennifer Jarrett discussed lower prevalence of CLADIN 18.2, TIGIT's lower toxicity, and testing challenges for CLADIN 18.2.