On January 10, 2022 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that updates on clinical programs and key milestones anticipated in 2022 (Press release, Arcus Biosciences, JAN 10, 2022, View Source [SID1234598542]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our priorities for 2022 are clear and unambiguous—to flawlessly execute on the expansion of our global clinical programs which will include more than 10 randomized Phase 2 and 3 studies. We also expect to present randomized datasets from ARC-7 and ARC-8 at medical meetings and generate early data for AB521 that will clarify its potential as a best-in-class molecule," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus Biosciences. "Our strong cash position and the support from our partner Gilead Sciences enable earlier investment to intelligently advance a broad development plan for our novel and potentially practice-changing combinations to treat cancer."

Program Updates and 2022 Milestones

Anti-TIGIT program (domvanalimab and AB308)

Recent Updates:

Taiho Pharmaceutical Co., Ltd., exercised its option for domvanalimab and AB308 in Japan and certain other territories in Asia (excluding China). In exchange for the exclusive license, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.
Anticipated 2022 Milestones:

Data from ARC-7, an ongoing randomized 150-patient three-arm study in first-line PD-L1≥50% NSCLC, including progression-free survival data, are expected to be presented in 2H22.
In addition to ARC-10, an ongoing registrational study in 1L PD-L1≥50% NSCLC, we and Gilead plan to initiate two new Phase 3 studies in lung and gastrointestinal (GI) cancers, as well as additional clinical studies of domvanalimab-based combinations, in 2022.
AstraZeneca and Arcus will initiate the PACIFIC-8 registrational Phase 3 study in January to evaluate domvanalimab plus durvalumab, an anti-PD-L1 antibody, in unresectable Stage 3 NSCLC with curative intent, where durvalumab is standard of care.
Data from the Phase 1/1b ARC-12 study evaluating AB308, an Fc-enabled anti-TIGIT antibody, plus zimberelimab in advanced malignancies will inform future development plans.
Etrumadenant (A2a/A2b adenosine receptor antagonist)

ARC-4 Update:

The randomized Phase 1/1b study ARC-4 did not show differentiated clinical activity for etrumadenant plus zimberelimab and pemetrexed/carboplatin compared to that of zimberelimab and pemetrexed/carboplatin in patients with metastatic, EGFRm+ NSCLC who progressed after one or more TKI therapies. Arcus is conducting exploratory biomarker analyses to assess whether sub-populations of patients in the study derive benefit from etrumadenant-based treatment, such as those with PD-L1 high tumors. Final data from the study will be presented when available.
All ongoing studies for etrumadenant will continue unchanged. These studies are in settings where encouraging clinical activity has been observed, such as PD-L1≥50% NSCLC (ARC-7), castrate-resistant prostate cancer (CRPC; ARC-6), and colorectal cancer (CRC; ARC-9). Patients whose tumors harbor EGFRm+ characteristics are excluded from the ARC-7 and ARC-10 studies.
Anticipated 2022 Milestones:

Data from the etrumadenant-containing arm of ARC-7 are anticipated to be presented in 2H22, as noted above.
Data from the randomized cohort of ARC-6 evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in second-line (2L) metastatic CRPC are anticipated in 2H22.
Additional clinical studies for etrumadenant-based combinations, including the "triplet" of etrumadenant plus domvanalimab and zimberelimab, are being planned for 2022.
Quemliclustat (small molecule CD73 inhibitor)

Recent Updates:

Completed enrollment of 90 patients into the randomized portion of ARC-8, a Phase 1 study evaluating quemliclustat plus zimberelimab and gemcitabine/nab-paclitaxel vs quemliclustat plus gemcitabine/nab-paclitaxel in 1L pancreatic cancer.
Anticipated 2022 Milestones:

Results from the randomized portion of ARC-8, including data on progression-free survival, are expected to be presented in 2H22.
Enrollment of the cohort in 2L pancreatic cancer, an area of high unmet need, is on track to be completed in 1H22.
Additional clinical studies for quemliclustat are being planned for 2022.
AB521 (HIF-2a inhibitor)

Recent Updates:

Initiated ARC-14, a study to investigate the safety, tolerability, and pharmacokinetic profile of AB521 in healthy volunteers.
Anticipated 2022 Milestones

Share pharmacokinetic and safety data from ARC-14 in 1H22, which may demonstrate competitive advantages to other HIF-2a inhibitors.
Initiate Phase 1/1b study in oncology patients in mid-2022.
Discovery Programs:

Added a research collaboration to the existing agreement with Gilead under which Arcus will lead the discovery and early development of drug candidates against two novel research targets jointly selected by the parties.
Selected AB598 (CD39 antibody) as a development candidate, which is advancing into IND-enabling studies; several other oncology discovery programs continue to progress.
In 1H22, expect to select the first development candidate for a non-oncology target. This small molecule may have first-in-class potential in several inflammatory diseases.
Financial Guidance

Arcus’s cash position will nearly double to $1.4 billion, upon receiving the option payment totaling $725 million for three programs from Gilead. With this cash position and 50/50 cost sharing with Gilead for the joint development programs, Arcus plans to expand its clinical development programs and anticipates cash utilization of $275-325 million in 2022.

Arcus Clinical Study Overview

Trial

Name

Arms

Setting

Status

NCT No.

ARC-4

etruma + zim + carbo/pem vs.

zim + carbo/pem

TKI R/R EGFRmut NSCLC

Ongoing

Randomized

Phase 1/2

NCT03846310

ARC-6

etruma + zim + SOC vs. SOC

2L/3L CRPC

Ongoing

Randomized

Phase 2

NCT04381832

ARC-7

zim vs. zim + dom vs. zim +

dom + etruma

1L NSCLC (PD-L1 ≥ 50%)

Ongoing

Randomized

Phase 2

NCT04262856

ARC-8

quemli + zim + gem/nab-pac

vs. quemli + gem/nab-pac

1L PDAC

Ongoing

Randomized

Phase 1/1b

NCT04104672

ARC-9

etruma + zim + mFOLFOX

vs. SOC

2L/3L/3L+ CRC

Ongoing

Randomized

Phase 2

NCT04660812

ARC-10

chemo vs. zim vs. zim + dom

1L NSCLC (PD-L1 ≥ 50%)

Ongoing

Registrational

NCT04736173

ARC-12

AB308 + zim

Advanced Malignancies

Ongoing

Phase 1/1b

NCT04772989

ARC-14

AB521

Healthy Volunteer

Ongoing

NCT05117554

PACIFIC-8

durva ± dom

Curative-Intent Stage 3 NSCLC

Planned

Registrational

NA

Carbo/pem: carboplatin/pemetrexed; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; quemli: quemliclustat; R/R: relapsed/refractory; SOC: standard of care; zim: zimberelimab CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma