RCUS Arcus Biosciences Inc.

36.03
+0.03  (+0%)
Previous Close 36.01
Open 36.33
52 Week Low 16.69
52 Week High 42.36
Market Cap $2,572,684,123
Shares 71,394,037
Float 50,339,817
Enterprise Value $1,835,373,639
Volume 724,892
Av. Daily Volume 470,349
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
AB680 +Zimberelimab (AB122) - ARC-8
Pancreatic Cancer
Phase 1
Phase 1
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Domvanalimab (AB154) + Zimberelimab (AB122) (ARC-7)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Etrumadenant, carboplatin, pemetrexed (ARC-4)
Non-small cell lung cancer
Phase 1/2
Phase 1/2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
AB928, AB680 and zimberelimab - ARC-6
Metastatic castrate-resistant prostate cancer (mCRPC)
Phase 1/2
Phase 1/2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Etrumadenant (AB928) + Zimberelimab (AB122)
Solid tumors
Phase 1
Phase 1
Phase 1b trial ongoing.
Domvanalimab (AB154) and IMFINZI (Durvalumab) - PACIFIC-8
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial to commence 2H 2021.
AB308 and zimberelimab (ARC-12)
Solid tumors
Phase 1
Phase 1
Phase 1 trial initiated 2Q 2021.
Etrumadenant plus mFOLFOX-6 (ARC-3)
Colorectal cancer
Phase 1
Phase 1
Phase 1 updated data presented at AACR April 10, 2021. Median progression-free survival (PFS) of 4.2 months. Median overall survival (OS) of 13.6 months. Objective response rate (ORR) of 9.1%.
Etrumadenant (AB928) and zimberelimab
Colorectal Cancer
Phase 1/2
Phase 1/2
Phase 1b/2 trial initiation announced April 10, 2021.
Domvanalimab + zimberelimab vs. zimberelimab vs. chemotherapy (ARC-10)
Non Small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial has been initiated.
Etrumadenant + eganelisib (IPI-549) - ARC-2
Triple negative breast cancer (TNBC) and ovarian cancer
Phase 1
Phase 1
Phase 1 initial data due presented at SABCS Annual Meeting, December 9, 2020. 2/18 response rate (partial responses - PR) for doublet regimen. 5/12 responses for triplet (1 complete response, 4 had a PR).

Latest News

  1. Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that management will present at the following upcoming September 2021 virtual investor conferences.

    • Citi's 16th Annual Virtual Biopharma Conference, Friday, September 10 at 1:25 pm ET
    • 2021 Cantor Virtual Global Healthcare Conference, Monday, September 27 at 4:40 pm ET

    A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least two weeks following the live event.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging…

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that management will present at the following upcoming September 2021 virtual investor conferences.

    • Citi's 16th Annual Virtual Biopharma Conference, Friday, September 10 at 1:25 pm ET
    • 2021 Cantor Virtual Global Healthcare Conference, Monday, September 27 at 4:40 pm ET

    A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least two weeks following the live event.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has five molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, and non-small cell lung. Quemliclustat (AB680), the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development in combination with zimberelimab and gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic cancer. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study evaluating zimberelimab monotherapy, domvanalimab plus zimberelimab and domvanalimab plus etrumadenant plus zimberelimab for first-line treatment of PD-L1 ≥ 50% metastatic non-small cell lung cancer (NSCLC). In addition, domvanalimab has advanced into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab plus domvanalimab and is expected to advance into a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage 3 NSCLC setting later this year. AB308, an anti-TIGIT antibody that is FcR-enabled, is in clinical development, with a potential focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Source: Arcus Biosciences

    View Full Article Hide Full Article
  2. Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that management will present at the 2021 Wedbush PacGrow Virtual Healthcare Conference on Wednesday, August 11, 2021 at 1:45 p.m. Eastern Time.

    A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least two weeks following the live event.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel…

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that management will present at the 2021 Wedbush PacGrow Virtual Healthcare Conference on Wednesday, August 11, 2021 at 1:45 p.m. Eastern Time.

    A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least two weeks following the live event.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has five molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, and pancreatic cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development in combination with zimberelimab and gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic cancer. Domvanalimab (AB154) is an Fc-silent anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy. In addition to ARC-7, domvanalimab is being investigated in a registrational, Phase 3 study, ARC-10, a "two in one trial" to support the potential approvals of both zimberelimab alone and domvanalimab plus zimberelimab compared to chemotherapy in first-line locally advanced or metastatic, PD-L1>50% NSCLC. An additional registrational Phase 3 study is being planned in collaboration with AstraZeneca in earlier disease with curative intent. AB308, an anti-TIGIT antibody that is Fc-enabled, is in clinical development, with a potential focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Source: Arcus Biosciences

    View Full Article Hide Full Article
    • Company to Host Conference Call on Thursday, August 5, 2021, at 1:30 pm PT/4:30 pm ET

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that the company will report its financial results for the second quarter ended June 30, 2021 after the market closes on Thursday, August 5, 2021.

    Management will host a conference call on August 5, 2021 to discuss second quarter 2021 financial results and recent corporate highlights. The call will begin at 1:30 pm PT/ 4:30 pm ET. Investors interested in listening to the conference call may do so by dialing (844) 200-6205 in the U.S. or +44 208 0682 558 internationally, using Conference ID: 152804. In addition…

    • Company to Host Conference Call on Thursday, August 5, 2021, at 1:30 pm PT/4:30 pm ET

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that the company will report its financial results for the second quarter ended June 30, 2021 after the market closes on Thursday, August 5, 2021.

    Management will host a conference call on August 5, 2021 to discuss second quarter 2021 financial results and recent corporate highlights. The call will begin at 1:30 pm PT/ 4:30 pm ET. Investors interested in listening to the conference call may do so by dialing (844) 200-6205 in the U.S. or +44 208 0682 558 internationally, using Conference ID: 152804. In addition, the live webcast and any accompanying slides will be available on the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company's website for at least two weeks following the live event.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has five molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, and pancreatic cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development in combination with zimberelimab and gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic cancer. Domvanalimab (AB154) is an Fc-silent anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy. In addition to ARC-7, domvanalimab is being investigated in a registrational, Phase 3 study, ARC-10, a "two in one trial" to support the potential approvals of both zimberelimab alone and domvanalimab plus zimberelimab compared to chemotherapy in first-line locally advanced or metastatic, PD-L1>50% NSCLC. An additional registrational Phase 3 study is being planned in collaboration with AstraZeneca in earlier disease with curative intent. AB308, an anti-TIGIT antibody that is Fc-enabled, is in clinical development, with a potential focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Source: Arcus Biosciences

    View Full Article Hide Full Article
  3. - ARC-7 and the ongoing ARC-10 Phase 3 registrational study will continue to enroll as planned, and preparations for additional Phase 3 studies are underway for domvanalimab-based combinations across various cancer types

    - Zimberelimab monotherapy showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting

    - At time of data cut off, no unexpected safety signals were observed in the ARC-7 study

    - Data will be submitted later this year for presentation at a medical meeting

    - Gilead is anticipated to make a decision regarding opting into the Arcus anti-TIGIT program later this year

    - Arcus will host a conference call today, Wednesday, June 23, 2021 at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time to provide an

    - ARC-7 and the ongoing ARC-10 Phase 3 registrational study will continue to enroll as planned, and preparations for additional Phase 3 studies are underway for domvanalimab-based combinations across various cancer types

    - Zimberelimab monotherapy showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting

    - At time of data cut off, no unexpected safety signals were observed in the ARC-7 study

    - Data will be submitted later this year for presentation at a medical meeting

    - Gilead is anticipated to make a decision regarding opting into the Arcus anti-TIGIT program later this year

    - Arcus will host a conference call today, Wednesday, June 23, 2021 at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time to provide an update on its ongoing domvanalimab program

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that, at the first interim analysis of the three-arm randomized Phase 2 ARC-7 study, both arms with domvanalimab-based combinations showed encouraging clinical activity (measured by overall response rate; ORR) when given as an initial treatment (first-line) to people with metastatic, PD-L1≥50% non-small cell lung cancer (NSCLC). The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting. At the time of data cut off, no unexpected safety signals were observed; and the current safety profile for each arm of the study appears to be consistent with known immune checkpoint inhibitors in this setting. All three arms of the ARC-7 trial, and the ongoing ARC-10 Phase 3 registrational study, will continue to enroll as planned; and ARC-7 data will be submitted later this year for presentation at a medical conference.

    Our partner Gilead Sciences has an exclusive option to co-develop and co-commercialize domvanalimab and is anticipated to make a decision regarding opting into the anti-TIGIT program later this year. Arcus and Gilead will continue preparations for additional Phase 3 studies of domvanalimab-based combinations and explore development plans for combinations including domvanalimab and etrumadenant.

    "This analysis of the dataset for the ongoing ARC-7 study revealed encouraging clinical activity for the anti-TIGIT domvanalimab-based combinations, and furthermore, that the anti-PD-1 zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting," said Bill Grossman, M.D., Ph.D., Chief Medical Officer of Arcus. "Next steps are to complete enrollment in all our open domvanalimab studies, execute on our broader plans for Phase 3 studies for domvanalimab across multiple cancer types, and further explore combinations with domvanalimab and etrumadenant."

    Conference call details

    Arcus will host a conference call and live webcast today, Wednesday, June 23, 2021 at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time to provide an update on its ongoing domvanalimab program. Investors interested in listening to the conference call may do so by dialing (877) 209-6698 in the U.S. or (825) 312-2373 internationally, using Conference ID: 6891607. In addition, the live webcast and accompanying slides will be available on the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company's website for approximately 30 days.

    About ARC-7 and the domvanalimab Development Program

    ARC-7 is an open-label randomized Phase II study evaluating the safety and efficacy of domvanalimab plus zimberelimab (anti-PD1 antibody) vs. zimberelimab alone vs. domvanalimab plus zimberelimab and etrumadenant (dual adenosine A2a/A2b receptor antagonist) in 150 people as a first-line treatment for PD-L1 ≥ 50% and EGFR/ALK wild-type, metastatic NSCLC. Participants are being randomized 1:1:1 across three study arms and treated until disease progression or loss of clinical benefit. Co-primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, duration of response and disease control rates. In this first interim analysis, data were not mature, and PFS was not assessed.

    In addition to ARC-7, domvanalimab is currently being evaluated in ARC-10, an ongoing registrational Phase 3 study evaluating domvanalimab plus zimberelimab vs. zimberelimab alone vs. chemotherapy in first-line locally advanced or metastatic, PD-L1>50% NSCLC. Based on the ARC-7 data, additional Phase 3 studies are planned for domvanalimab-based combination across various cancer types.

    About domvanalimab and Arcus' anti-TIGIT program

    Domvanalimab, Arcus' most advanced anti-TIGIT candidate, is an Fc-silent investigational monoclonal antibody that binds to TIGIT, a protein receptor on immune cells that acts as a brake on the immune response. Cancer cells can exploit TIGIT to avoid detection by the immune system. Domvanalimab binds to TIGIT to free up immune activating pathways and activate immune cells to attack and kill cancer cells.

    Arcus is developing a second anti-TIGIT candidate, AB308, an Fc-enabled investigational monoclonal antibody in clinical development, with a potential focus on hematological malignancies. AB308 is currently in Phase I studies for advanced malignancies.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has five molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, and pancreatic cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development in combination with zimberelimab and gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic cancer. Domvanalimab (AB154) is an Fc-silent anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy. In addition to ARC-7, domvanalimab is being investigated in a registrational, Phase 3 study, ARC-10, a "two in one trial" to support the potential approvals of both zimberelimab alone and domvanalimab plus zimberelimab compared to chemotherapy in first-line locally advanced or metastatic, PD-L1>50% NSCLC. An additional registrational Phase 3 study is being planned in collaboration with AstraZeneca in earlier disease with curative intent. AB308, an anti-TIGIT antibody that is Fc-enabled, is in clinical development, with a potential focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com or follow us on Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein, including, but not limited to, the continuation of preparations for additional phase 3 studies with domvanalimab, the exercise and timing of Gilead's exclusive option to our TIGIT program, and the acceptance and timing of any presentation of the ARC-7 data at a medical meeting, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Arcus's actual results, performance, or achievements to differ significantly from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary or interim data from ongoing trials; our dependence on our collaboration with Gilead for the successful development and commercialization of our investigational products; changes in the competitive landscape for our programs; uncertainty associated with the COVID-19 pandemic, including the duration and/or severity of the outbreak and actions by government authorities to contain or slow the spread of the virus; delays in our clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; the emergence of adverse events or other undesirable side effects; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in Arcus's quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed on May 5, 2021, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

    View Full Article Hide Full Article
    • In this first reported Phase 1b cohort, the etrumadenant-based combination was well tolerated with a composite overall response rate (ORR) of 41% in people previously treated for metastatic castrate-resistant prostate cancer (mCRPC)
    • Etrumadenant is the first dual adenosine A2a/A2b receptor antagonist to demonstrate evidence of clinical activity in prostate cancer
    • Data provide further support for the potential role of adenosine receptor blockade in the treatment of certain cancer types, particularly in those that are considered to be non-responsive to anti-PD-(L)1 therapy 

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced initial efficacy…

    • In this first reported Phase 1b cohort, the etrumadenant-based combination was well tolerated with a composite overall response rate (ORR) of 41% in people previously treated for metastatic castrate-resistant prostate cancer (mCRPC)
    • Etrumadenant is the first dual adenosine A2a/A2b receptor antagonist to demonstrate evidence of clinical activity in prostate cancer
    • Data provide further support for the potential role of adenosine receptor blockade in the treatment of certain cancer types, particularly in those that are considered to be non-responsive to anti-PD-(L)1 therapy 

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced initial efficacy and safety data from one of the cohorts in ARC-6, a randomized Phase 1b/2 platform study, evaluating the novel combination of etrumadenant (dual adenosine A2a/A2b receptor antagonist) plus zimberelimab (anti-PD1 antibody) and docetaxel in people with taxane-naïve mCRPC who progressed following treatment with one or more new hormonal agents and were checkpoint inhibitor-naïve. In this Phase 1b cohort of the etrumadenant-based combination, a composite ORR (radiographic and/or PSA [prostate-specific antigen] response) of 41% and a PSA response of 35% were observed. The safety profile was consistent with the known profiles of each individual agent, and no significant additive toxicity was observed with the addition of etrumadenant. These data will be presented in a poster session at the American Society of Clinical Oncology Annual Meeting taking place June 4-8.

    "We are encouraged by these early data that indicate the etrumadenant-based combination is well tolerated and demonstrates promising clinical activity in people with advanced disease who progressed on prior treatments," said Bill Grossman, M.D., Ph.D., Chief Medical Officer of Arcus. "Based on these data, we have initiated enrollment into the randomized Phase 2 portion of this arm in the ARC-6 platform study, which compares the etrumadenant-based regimen to standard of care."

    "Prostate tumors produce high levels of adenosine, which is believed to be immunosuppressive," said Sumit K. Subudhi, M.D., Ph.D., Department of Genitourinary Medical Oncology, Division of Cancer Medicine at the University of Texas, M.D. Anderson Cancer Center. "I am encouraged by the early evidence of clinical response and composite ORR of 41% observed in this study cohort, indicating adenosine receptor blockade with an etrumadenant-based combination may have a role in the treatment of prostate cancer."

    ARC-6: A Phase 1b/2, Open-Label, Randomized Platform Study to Evaluate Efficacy and Safety of Etrumadenant (AB928)-Based Treatment Combinations in Patients with Metastatic Castrate-Resistant Prostate Cancer (Abstract 5039)

    As of the data cut-off (DCO) of April 9, 2021, 17 people (n=17) had received the etrumadenant-based combination in this cohort of the Phase 1b portion of the study. Median time on treatment was 4.2 months (range: 2.1-8.3+ months), and 11 people remained on study treatment at time of DCO. For this cohort, all people had received prior systemic therapy but were taxane naive; most (13/17; 76%) had received ≥1 prior anti-androgen, and 11/17 people (65%) had received prior abiraterone.

    Safety Analyses:

    • People in this cohort of the study were administered 150 mg of etrumadenant orally once daily plus 360 mg of zimberelimab and 75mg/m2 of docetaxel intravenously every three weeks.
    • All people experienced treatment emergent adverse events (TEAE), and the most common TEAEs were alopecia (53%), lymphocyte count decreases (53%) and fatigue (47%).
    • Grade 3 or 4 related TEAEs were reported for 6/17 (35%) people; all of these events were related to etrumadenant and may also be attributed to zimberelimab and/or docetaxel.
    • No treatment emergent serious adverse events (TESAEs) were considered related to etrumadenant.

    Clinical Activity:

    • The composite ORR (radiographic and/or PSA response) was 41% (7/17) per the Prostate Cancer Working Group 3 (PCWG3) criteria.
    • Six people (35%) had a >50% decrease in PSA level, and seven people (41%) had non-response/non-progression.
    • All 11 people with RECIST measurable or non-measurable disease experienced clinical benefit (stable disease or better).
      • One unconfirmed complete response (CR) was observed in a person with only non-target disease remaining.
      • Two confirmed partial responses (PRs) were observed; one person with PR also had improvement in bone disease burden.

    The safety and clinical activity data from this cohort of ARC-6 add to the emerging body of evidence that adenosine receptor blockade with an etrumadenant-based combination may have a role in the treatment of certain cancers. Based on these results, Arcus has initiated the randomized portion of this cohort which is evaluating this etrumadenant-based combination compared to docetaxel, the current standard of care for this setting.

    Additional information about this poster presentation may be found on the Arcus website at Arcus Publications on June 4.

    In addition to ARC-6, etrumadenant is currently being evaluated in three randomized Phase 2 studies:

    • ARC-7 is evaluating domvanalimab (anti-TIGIT antibody) plus zimberelimab vs. zimberelimab alone vs. domvanalimab plus zimberelimab and etrumadenant in first-line metastatic, PD-L1>50%, locally advanced or metastatic non-small cell lung cancer (NSCLC), with an interim analysis planned for this quarter.
    • ARC-4 is evaluating etrumadenant plus chemotherapy and zimberelimab vs. chemotherapy plus zimberelimab in second-line (2L) or third-line (3L) EGFR-positive NSCLC. Data from this study are expected in the second half of 2021.
    • ARC-9 is evaluating etrumadenant-based combinations in 2L and 3L metastatic colorectal cancer (mCRC). These data build on the results of ARC-3, a Phase 1/1b open-label study of etrumadenant plus chemotherapy in people with mCRC, which showed encouraging tolerability and efficacy in the 3L setting compared to standard of care. Data from this study are expected in the first half of 2022.

    About Etrumadenant

    Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist in the clinic, is designed to maximally inhibit the adenosine-driven impairment of tumor-infiltrating lymphocytes (mainly CD8+ T cells and NK cells) and myeloid cells (dendritic cells, macrophages), mediated by A2aR and A2bR, respectively. A2bR is also upregulated by certain cancer cells, such as in prostate cancer and KRAS-mutated cancers. As a result, etrumadenant may uniquely block adenosine's immunosuppressive and cancer cell-intrinsic effects. Developed specifically for the oncology setting, etrumadenant achieves high penetration of tumor tissue, robust potency in the presence of high adenosine concentrations, and minimal shift in potency from non-specific protein binding. Etrumadenant has demonstrated a favorable safety profile with a variety of combination regimens and exhibits pharmacokinetics / pharmacodynamics consistent with once-daily oral dosing. AB928 is currently being evaluated in several Phase 1b/2 studies across multiple indications.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has five molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, and pancreatic cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development in combination with zimberelimab and gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic cancer. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study evaluating zimberelimab monotherapy, domvanalimab plus zimberelimab and domvanalimab plus etrumadenant plus zimberelimab for first-line treatment of PD-L1 ≥ 50% metastatic non-small cell lung cancer (NSCLC). In addition, domvanalimab has advanced into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab plus domvanalimab and is expected to advance into a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage 3 NSCLC setting later this year. AB308, an anti-TIGIT antibody that is FcR-enabled, is in clinical development, with a potential focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com or follow us on Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein, including, but not limited to, the potential role of adenosine receptor blockade in the treatment of certain cancer types, and anticipated milestones and associated timelines are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Arcus's actual results, performance, or achievements to differ significantly from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: the inherent uncertainty associated with pharmaceutical product development and clinical trials; risks associated with preliminary or interim data from ongoing trials; the emergence of adverse events or other undesirable side effects; the inherent uncertainty associated with the COVID-19 pandemic, including the duration and/or severity of the outbreak and actions by government authorities to contain or slow the spread of the virus; delays in our clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; changes in the competitive landscape for our programs; and our dependence on our collaboration with Gilead for the successful development and commercialization of our investigational products. Risks and uncertainties facing Arcus are described more fully in Arcus's quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed on May 5, 2021, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

    View Full Article Hide Full Article
View All Arcus Biosciences Inc. News