On April 23, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that updated data from an ongoing, global Phase 1a/1b clinical trial (NCT06179069) evaluating ZL-1310, the Company’s potential first-in-class and best-in-class, Delta-like ligand (DLL3) antibody-drug conjugate (ADC) for the treatment of extensive-stage small cell lung cancer (ES-SCLC), will be presented during a poster session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3, 2025 in Chicago, Illinois (Press release, Zai Laboratory, APR 23, 2025, View Source [SID1234652077]). The updated results will include additional patients and follow-up from the ongoing trial of ZL-1310 in patients with previously treated ES-SCLC after at least one prior platinum-based chemotherapy regimen.

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"ZL-1310 reflects our company’s commitment to develop differentiated oncology therapies that address current limitations with many first-generation and current standard-of-care treatments," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "We are focused on the development of ZL-1310, and we look forward to presenting updated results at ASCO (Free ASCO Whitepaper) 2025."

Details regarding the webcast and conference call are as follows:

Zai Lab will hold an investor conference call and webcast to highlight updated ZL-1310 data at ASCO (Free ASCO Whitepaper) and outline the next steps in clinical development.

Date/Time: Monday, June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT, please register at:
Webcast presentation (preferred): View Source;
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab

Details regarding the ZL-1310 poster presentation are as follows:

Title: ZL-1310, a DLL3 ADC, in patients with extensive stage small cell lung cancer: Ph1 trial update
Presenter: Manish R. Patel, M.D., Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL
Session Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date/Time: Monday, June 2, 2025, from 1:30 p.m. – 4:30 p.m. CT
Location: McCormick Place Convention Center, Hall A – Posters and Exhibits
Published Abstract Number: 3041
Poster Board: 356

About Small Cell Lung Cancer and ZL-1310

Small cell lung cancer (SCLC) is one of the most aggressive and lethal solid tumors, accounting for ~15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage3.

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

ZL-1310 received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in January 2025, recognizing its potential to treat patients with SCLC.

About the Webcast and Conference Call

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

On April 23, 2025 Incyte (Nasdaq: INCY) reported that multiple abstracts featuring new data from its oncology portfolio will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held May 30 – June 3, 2025, in Chicago (Press release, Incyte, APR 23, 2025, View Source [SID1234652076]).

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"The data featured at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, from both our approved medicines and early-stage pipeline, reflect our ongoing efforts to transform cancer care," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "We are advancing potential therapies across some of the most difficult-to-treat cancers and hematological diseases, including squamous cell anal cancer, ovarian cancer and myelofibrosis, with the hope of making a meaningful difference for these patients."

Key abstracts accepted for presentation:

Oral Presentations

INCB123667

Safety and Preliminary Efficacy from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Advanced Platinum-Resistant and Refractory Ovarian Cancer (OC)
(Abstract #5514. Session: Rapid Oral Abstract – Gynecologic Cancer. June 3, 9:42 a.m. ET (8:42 a.m. CT))

Pemigatinib

A Phase 2 Study of Pemigatinib for Pre-treated Glioblastoma or Other Gliomas with Activating FGFR1-3 Alterations: Results from FIGHT-209
(Abstract #2003. Session: Oral Abstract Session – Central Nervous System Tumors. May 30, 4:21 p.m. ET (3:21 p.m. CT))

Poster Presentations

Retifanlimab

Experience of Patients with HIV and Squamous Cell Carcinoma of the Anal Canal (SCAC) Treated with Retifanlimab
(Abstract #3521. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

POD1UM-303/INTERAACT2 Subgroup Analyses and Impact of Delayed Retifanlimab Treatment on Outcomes in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
(Abstract #3525. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

Final Results of POD1UM-201, a Phase 2 Study of Retifanlimab, a Humanized Anti–PD-1 Antibody, in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC)
(Abstract #9536. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

Long-term Outcomes After Discontinuation of Retifanlimab in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC) in the POD1UM-201 Trial
(Abstract #9538. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

INCB123667

Interim Safety and Antitumor Activity Data from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Metastatic Recurrent Endometrial Cancer
(Abstract #5603. Session: Gynecologic Cancer. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

INCB057643

Safety And Efficacy of Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 In Patients (pts) with Relapsed or Refractory Myelofibrosis (r/r-MF) and Other Advanced Myeloid Neoplasms: A Phase (Ph) 1 Study
(Abstract #6574. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT))

More information regarding the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at: View Source

About Pemazyre (pemigatinib)
Pemazyre (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a FGFR2 fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

In Canada, Pemazyre is approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe, Japan and Canada.

Pemazyre and the Pemazyre logo are registered trademarks of Incyte.

* Pemazyre (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.

About Zynyz (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Zynyz (retifanlimab) is approved as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

In Canada, Zynyz (retifanlimab) is approved as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

Zynyz is marketed by Incyte in the U.S., Europe and Canada, in 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

On April 23, 2025 Pfizer Inc. (NYSE: PFE) reported that it will showcase data across its portfolio of potential breakthrough cancer medicines at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 to June 3 in Chicago (Press release, Pfizer, APR 23, 2025, View Source [SID1234652075]). Data from more than 60 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 9 oral presentations and 6 rapid oral presentations, will be presented across Pfizer’s key tumor areas, including breast, genitourinary, hematologic, and thoracic cancers, as well as colorectal cancer.

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"This has already been a significant year for Pfizer’s Oncology pipeline, with multiple Phase 3 data readouts and regulatory approvals, and the initiation of pivotal registrational programs across our major tumor areas of focus," said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research & Development, Pfizer. "The depth and diversity of our data presentations at ASCO (Free ASCO Whitepaper) are building on that momentum to bring us closer to our goal of delivering eight breakthrough cancer medicines by 2030."

Pfizer will have two late-breaking oral presentations featured in ASCO (Free ASCO Whitepaper)’s embargoed pre-meeting press briefing on May 27. These include the primary analysis of the pivotal overall survival (OS) and progression-free survival (PFS) results from the Phase 3 BREAKWATER study investigating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer,* as well as the first presentation of the PFS results from the Phase 3 VERITAC-2 study of vepdegestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (a/mBC) in partnership with Arvinas.**

Pfizer will share additional updates from key late-stage programs, including five-year survival data from the Phase 3 ARCHES study of XTANDI (enzalutamide) in combination with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer (mHPSC),*** and the first combination data for ELREXFIO (elranatamab) + daratumumab + lenalidomide from the ongoing MagnetisMM-6 study in patients with transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM).

Pfizer will also share new findings highlighting the company’s strategy to explore novel vedotin antibody-drug conjugates (ADCs) in combination with immune checkpoint inhibitors to potentially enhance anti-tumor activity. For the first time, Pfizer will present encouraging Phase 1 data on two novel investigational ADCs in combination with pembrolizumab in thoracic cancers: sigvotatug vedotin (SV), an integrin beta-6 (IB6)-directed ADC, in lung cancer and head and neck cancers, and PDL1V (PF-08046054), a PD-L1 directed ADC, in head and neck cancers. Additionally, new exploratory analyses will be presented from the pivotal EV-302 trial with PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).****

Several presentations will highlight updated results from ongoing Phase 1 studies that inform the dosing strategy in registrational programs for two molecules targeting epigenetic regulators: mevrometostat, an investigational EZH2 inhibitor being evaluated in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC); and PF-07248144, a potential first-in-class KAT6 inhibitor for ER+/HER2- metastatic breast cancer (mBC).

"Our data at ASCO (Free ASCO Whitepaper) this year reflect how we are strategically progressing our deep pipeline of next generation cancer medicines while simultaneously extending the impact of our foundational therapies to reach more people living with cancer," said Megan O’Meara, Head of Early-Stage Development and Interim Head of Late-Stage Development, Pfizer Oncology. "Important early-stage updates highlight our extensive pipeline and depth within our core cancer types, as we advance up to nine new pivotal Phase 3 trials this year."

Key ASCO (Free ASCO Whitepaper) Presentations

Colorectal Cancers

BRAFTOVI: A late-breaking session will detail PFS and OS results from the Phase 3 BREAKWATER study of BRAFTOVI in combination with cetuximab and mFOLFOX6 chemotherapy in BRAF V600E-mutant metastatic colorectal cancer, further establishing the benefit of the BRAFTOVI combination regimen following its FDA accelerated approval in late 2024. These pivotal study results follow the topline results announcement for PFS and OS and the objective response rate (ORR) results presented at ASCO (Free ASCO Whitepaper) GI. These new data will also be featured in the ASCO (Free ASCO Whitepaper) press program.
Breast Cancer

Vepdegestrant: In a late-breaking session, PFS data will be presented for the first time from the Phase 3 VERITAC-2 study of vepdegestrant, a PROTAC ER degrader, in ER+/HER2− a/mBC. These detailed data follow the topline results from VERITAC-2 announced earlier this year and will also be featured in the ASCO (Free ASCO Whitepaper) press program.
PF-07248144 (KAT6 inhibitor): A rapid oral presentation will highlight dose optimization data from an ongoing Phase 1 study for PF-07248144, a potential first-in-class KAT6 inhibitor, in patients with ER+/HER2− mBC. These results support the recommended dosing for PF-07248144 ahead of the Phase 3 trial initiation in second-line mBC planned for 2H 2025.
IBRANCE (palbociclib): Roche will present detailed results from the OS analysis of the Phase 3 INAVO120 study investigating ITOVEBI (inavolisib) in combination with IBRANCE and fulvestrant in patients with PIK3CA-mutated, HR+/HER2-, endocrine-resistant, locally a/mBC. This presentation will be featured in ASCO (Free ASCO Whitepaper)’s embargoed pre-meeting press briefing on May 21.
Genitourinary Cancers

XTANDI: Five-year follow-up overall survival data from the ARCHES study of XTANDI in combination with androgen deprivation therapy in patients with mHSPC will be featured in an oral presentation. In addition, updates from the Astellas-supported, investigator-sponsored ENZAMET Phase 3 research study, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by the University of Sydney, will also be presented, including 8 year-outcomes in men with mHSPC. These presentations further underscore the value of XTANDI across approved indications.
Mevrometostat: A poster presentation will highlight pharmacokinetic and safety data from the ongoing Phase 1 study for mevrometostat, an investigational EZH2 inhibitor, in combination with XTANDI. These updated data further inform the dosing strategy for mevrometostat in a robust registrational program that includes two Phase 3 trials in mCRPC, and a third trial in metastatic castration-sensitive prostate cancer (mCSPC) that is planned to start in 1H 2025.
PADCEV: Additional updates from the Phase 3 EV-302 study of PADCEV in combination with KEYTRUDA in previously untreated la/mUC will be presented, including an oral presentation with exploratory analysis of responders.
Hematologic Cancers

ELREXFIO: Initial safety and efficacy results from Part 1 of the ongoing MagnetisMM-6 study of ELREXFIO in combination with daratumumab and lenalidomide in patients with newly diagnosed MM that are not eligible for transplant will be presented as an oral presentation. Part 1 of the ongoing MagnetisMM-6 study evaluates the optimal dose of the ELREXFIO combination regimen in patients with RRMM or NDMM to determine the recommended phase 3 dose for part 2.
Thoracic Cancers

Sigvotatug vedotin (SV): Phase 1 results for SV, an IB6-directed vedotin ADC, in combination with pembrolizumab in non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) will be featured in a rapid oral presentation. This initial combination data for SV with pembrolizumab support a Phase 3 study in first line PD-L1-High NSCLC, initiated this year. The data also support the overall SV trial program that includes an ongoing Phase 3 monotherapy trial in second line+ NSCLC.
PDL1V (PF-08046054): Two poster presentations will highlight interim Phase 1 results for PDL1V, a PD-L1 directed vedotin ADC, as monotherapy in NSCLC and initial safety and efficacy data in combination with pembrolizumab in patients with first-line recurrent or metastatic (r/m) HNSCC. These data provide additional support for the initiation of the two pivotal Phase 3 trials planned for PDL1V in 2025 in second line+ NSCLC and first line r/mHNSCC.
Additional information on key Pfizer-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here.

Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO (Free ASCO Whitepaper), which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting May 22, 2025.

COLORECTAL CANCERS

Oral Presentation (Abstract LBA3500)

Friday, May 30, 2:45-5:45 PM CDT

First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): progression-free survival and updated overall survival analyses

Elez et al

BREAST CANCER

Rapid Oral Presentation (Abstract 1020)

Friday, May 30, 2:45-4:15 PM CDT

Dose optimization of PF-07248144, a first-in-class KAT6 inhibitor, in patients (pts) with ER+/HER2− metastatic breast cancer (mBC): Results from phase 1 study to support the recommended phase 3 dose (RP3D)

LoRusso et al

Oral Presentation (Abstract LBA1000)

Saturday, May 31, 1:15-4:15 PM CDT

Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study

Hamilton et al

GENITOURINARY CANCERS

Oral Presentation (Abstract 4502)

Sunday, June 1, 9:45 AM-12:45 PM CDT

Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)

Gupta et al

Oral Presentation (Abstract 5005)

Tuesday, June 3, 9:45 AM-12:45 PM CDT

ARCHES 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC)

Armstrong et al

Poster Presentation (Abstract 4571)

Monday, June 2, 9:00 AM-12:00 PM CDT

EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)

Bedke et al

Poster Presentation (Abstract 5046)

Monday, June 2, 9:00 AM-12:00 PM CDT

Safety and pharmacokinetics of mevrometostat (M) in combination with enzalutamide (E) in patients with metastatic castration-resistant prostate cancer (mCRPC)

Matsubara et al

HEMATOLOGIC CANCERS

Oral Presentation (Abstract 7504)

Tuesday, June 3, 9:45 AM-12:45 PM CDT

Elranatamab in combination with daratumumab and lenalidomide (EDR) in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant: Initial results from MagnetisMM-6 part 1

Quach et al

THORACIC CANCERS

Rapid Oral Presentation (Abstract 3010)

Monday, June 2, 8:00-9:30 AM CDT

Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001)

Sehgal et al

Poster Presentation (Abstract 6033)

Monday, June 2, 9:00 AM-12:00 PM CDT

Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC

Gillison et al

Poster Presentation (Abstract 8611)

Saturday, May 31, 1:30-4:30 PM CDT

Interim results of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in patients with NSCLC in a phase 1 trial

Fontana et al

*The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company.
**Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant.
***XTANDI is jointly developed and commercialized by Pfizer and Astellas in the United States.
****Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV and KEYTRUDA in patients with previously untreated metastatic urothelial cancer.

Prescribing Information for Pfizer Medicines

Please see full Prescribing Information for BRAFTOVI.

Please see full Prescribing Information, including BOXED WARNING, for ELREXFIO (elranatamab-bcmm).

Please see full Prescribing Information for IBRANCE (palbociclib) tablets and IBRANCE (palbociclib) capsules.

Please see full Prescribing Information, including BOXED WARNING, for PADCEV (enfortumab vedotin).

Please see full Prescribing Information for XTANDI (enzalutamide).

On April 23, 2025 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 data from the ARC-20 study will be presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3, 2025 (Press release, Arcus Biosciences, APR 23, 2025, View Source [SID1234652074]).

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The oral presentation will highlight the first safety and efficacy data for the ARC-20 expansion cohort evaluating the HIF-2a inhibitor casdatifan plus cabozantinib, an anti-vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor (VEGFR2-TKI), in patients with ccRCC that had previously been treated with immunotherapy alone or in combination with anti-VEGFR2-TKI therapies.

"We are thrilled to be presenting the first combination data evaluating our HIF-2a inhibitor, casdatifan, in combination with cabozantinib in an oral presentation at ASCO (Free ASCO Whitepaper)," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The data being presented support our rapidly advancing and differentiated development program for casdatifan, which includes the initiation of our Phase 3 trial, PEAK-1, that will evaluate the same combination as this cohort. The development plan also includes our clinical collaboration to evaluate casdatifan in combination with AstraZeneca’s PD-1/CTLA-4 bispecific antibody, volrustomig, in immuno-oncology-naive ccRCC patients. We look forward to presenting additional data from the ARC-20 study throughout the year."

Study

Title

Abstract Number

Session Type & Title

Session Date & Time

Casdatifan (HIF-2a Inhibitor)

ARC-20

Combination Casdatifan Plus Cabozantinib Expansion Cohort of Phase 1 ARC-20 Study in Previously Treated Patients with Clear Cell Renal Cell Carcinoma

4506

Oral Abstract Session – Genitourinary Cancer—Kidney and Bladder

6/01/2025,

9:45 AM – 12:45 PM CT

Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 446724 on Monday, June 2, 2025, at 5:00 AM PT / 7:00 AM CT. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2⍺, casdatifan is designed to shut down hypoxic oncogenesis, which blocks tumor growth and key oncogenic pathways, leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

On April 23, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "ONO") reported that it will present positive results from the Phase 2 PROSPECT study of tirabrutinib (ONO-4059) for the treatment of relapsed or refractory primary central nervous system lymphoma during an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held May 30 to June 3, 2025, in Chicago, Illinois (Press release, Ono, APR 23, 2025, View Source [SID1234652073]). The company will also present data on ONO-4578, an investigational EP4 antagonist, for the treatment of locally advanced resectable rectal cancer, during a poster presentation.

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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

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"We are fully committed to developing innovative drugs for cancer patients. This announcement is an important step forward in demonstrating that we can potentially provide new value to patients," said Tatsuya Okamoto, Corporate Officer / Executive Director, Clinical Development at ONO. "We aim to offer new treatment options in cancer care globally and contribute to improving patients’ quality of life."

Details for both studies and data to be presented are as follows:

Tirabrutinib (ONO-4059)
Abstract Title: Tirabrutinib for the treatment of relapsed or refractory primary central nervous system lymphoma: Efficacy and safety from the phase II PROSPECT study.
Abstract Submission ID: 487376
Session Type and Title: Rapid Oral Abstract – Central Nervous System Tumors
Session Date and Time: May 31, 2025, 3:00-4:30 PM CDT
Presenter: Lakshmi Nayak, MD, Dana-Farber Cancer Institute

ONO-4578
Abstract Title: Neoadjuvant ONO-4578, an EP4 antagonist, in combination with nivolumab after chemoradiation therapy in locally advanced resectable rectal cancer.
Session Type and Title: Poster Session Gastrointestinal Cancer – Colorectal and Anal
Abstract Number for Publication: 3588
Poster Board: 257
Session Date and Time: May 31, 2025, 9:00 AM-12:00 PM CDT
Presenter: Yusuke Takahashi, Lower Gastrointestinal Surgery, National Hospital Organization Osaka National Hospital