SELLAS to Present at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 23, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that preclinical efficacy of SLS009 in ASXL1 mutated colorectal cancer lines will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place May 30- June 3, 2025 in Chicago, Illinois (Press release, Sellas Life Sciences, APR 23, 2025, View Source [SID1234652059]).

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Poster presentation details:

Title: In vitro efficacy of CDK9 inhibitor tambiciclib (SLS009) in ASXL1 mutated colorectal cancer cell lines.

Session Date and Time: Monday, June 2, 2025, 1:30 PM-4:30 PM CDT

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Location: Hall A – Posters and Exhibits

Abstract #: 3121

Poster Board #: 436

The full text of the abstract will be released by ASCO (Free ASCO Whitepaper) on May 22, 2025, at 5:00 PM EDT on asco.org/abstracts.

SLS009 is currently being investigated in a Phase 2 open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine including AML patients with ASXL1 mutations. Initial clinical safety and efficacy data are available. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.

Pfizer Advances Bold Vision for Future of Cancer Care at the ASCO 2025 Annual Meeting

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).

Adcendo ApS to Present Data on its Clinical Stage ADCs ADCE-T02 and ADCE-D01 at the 2025 American Association for Cancer Research (AACR) Annual Meeting

On April 23, 2025 Adcendo ApS ("Adcendo"), a biotech company focused on the development of first and best-in-class ADCs for the treatment of cancers with high unmet medical need, reported it will be presenting data on its two novel ADC programs ADCE-T02, targeting Tissue Factor, and ADCE-D01, targeting uPARAP, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in Chicago, Illinois, from April 25th to April 30th, 2025 (Press release, ADCendo, APR 23, 2025, View Source [SID1234652044]).

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ADCE-T02 is a potential best-in-class Topo-1 inhibitor-based ADC targeting Tissue Factor (TF). Tissue Factor is clinically validated target overexpressed in a broad range of solid tumors, with limited expression in normal tissues. ADCE-T02 is composed of a next-generation TF targeting antibody conjugated to an exatecan-based T-1000 payload, a clinically validated linker-payload technology. ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models and is well tolerated in non-human primate toxicology studies with no evidence of toxicity from earlier generation TF ADCs. A phase 1 clinical trial in advanced solid tumors is ongoing in both Australia and the United States. Australian recruitment is underway and enrollment in the United States will be initiated in the near future [NCT06597721].

ADCE-D01 is a first-in-class ADC targeting uPARAP conjugated to the Topo-1 inhibitor payload P-1021. uPARAP is a novel endocytic ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas, while exhibiting restricted expression in normal tissues. ADCE-D01 is composed of a first-in-class uPARAP-targeting antibody conjugated to an optimized, clinically validated linker payload technology, selected for its superior efficacy and tolerability. Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including soft tissue sarcoma and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific toxicity. A phase 1 clinical trial in advanced soft tissue sarcomas is enrolling in the United States and is under regulatory review in the European Union [NCT06797999].

Dominik Mumberg, PhD, Chief Scientific Officer at Adcendo, said: "We are excited to share the promising preclinical data for ADCE-T02 and ADCE-D01 demonstrating strong anti-tumor activity across a broad range of epithelial and mesenchymal tumor models with highly favourable tolerability profiles. We look forward to advancing both programs in our phase 1 Tiffany-01 and ADCElerate1 trials to help cancer patients in need of novel therapeutic options."

Details of the poster presentations are as follows:

Date & Time: April 29th, 9.00am – 12.00pm CT
Session Title: Antibodies and Antibody-Drug Conjugates
Poster Section: 36

Board Number: 14, Abstract number: 4778
Presentation title: ADCE-T02: A first-in-class topoisomerase-1 inhibitor-based antibody drug conjugate against tissue factor demonstrates excellent preclinical efficacy and tolerability
Authors: T. T. Poulsen1, Y. Zhang2, J. Zhang2, H. Shi2, S. Liu3, X. Meng2, M. Gillberg1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 Multitude Therapeutics, Shanghai, China. 3 Multitude Therapeutics, Redwood City, CA, USA

Board Number: 20, Abstract number: 4784
Presentation title: ADCE-D01: a first in class antibody-drug conjugate against urokinase plasminogen activator receptor-associated protein (uPARAP) demonstrates excellent preclinical efficacy and tolerability
Authors: J. Wardman1, A. Bie1, C. Côme1, P. Barkholt1, S. van Putten1, C. Løkke1, I. Gregersen1, J. Lange1, M. Gilberg1, K. Bannister1, M. Krogh-Madsen1, T. T. Poulsen1, C. Nielsen1, L. Engelholm2, N. Behrendt2, C. Lynch1, P. Hemmingsen1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 The Finsen Laboratory, Rigshospitalet/BRIC, Copenhagen University, Copenhagen, Denmark

Abstracts are available in an online itinerary planner (ADCE-T02 abstract; ADCE-D01 abstract), and will be available in an online only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research one month after the conference. Electronic posters will be made available for registered conference participants from April 25th, 2025, through the conference web portal.

About antibody-drug conjugates (ADCs):

ADCs are a class of highly potent biopharmaceutical drug composed of a targeting antibody linked to a biologically active drug or cytotoxic compound. ADCs combine the unique and very sensitive targeting capabilities of antibodies, with the potent effects of the conjugated cytotoxic drugs, allowing sensitive discrimination between healthy and cancer tissues.

Alligator Bioscience AB reports financial results for Q1 2025 and provides a business update

On April 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported its results for the first quarter ending March 2025 (Press release, Alligator Bioscience, APR 23, 2025, View Source [SID1234652060]).

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" With the continued strengthening of mitazalimab’s clinical profile—including 24-month survival data, further dose validation, and positive regulatory alignment—we are well-positioned for Phase 3 initiation in the second half of 2025. Combined with enhanced financial flexibility following the rights issue and strategic portfolio optimization, we are advancing with confidence toward our goal of delivering transformative immunotherapies for patients with hard-to-treat cancers."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Announcement of encouraging overall survival benefit from the Phase 2 trial OPTIMIZE-1, with 24-month follow-up data showing a 29.4% survival rate for mitazalimab in combination with mFOLFIRINOX—three times higher than estimates for chemotherapy alone.
Top-line data from the 450 µg/kg back-filled cohort in OPTIMIZE-1 further support 900 µg/kg as the recommended Phase 3 dose.
Additional positive survival data for mitazalimab demonstrated through a literature-based indirect comparison, showing an incremental overall survival benefit and further supporting progression to Phase 3.
Successful completion of End-of-Phase 2 meeting with the FDA with positive feedback and alignment on clinical development strategy and Phase 3 trial design.
Company

Approval of rights issue and reverse share split at Extraordinary General Meetings held on 13 January and 27 March 2025, respectively.
Successful completion of rights issue in February 2025 with gross proceeds of SEK 153 million; BTUs converted and units issued to guarantors and Fenja Capital.
Peer-reviewed publication of data for ATOR-1017 (evunzekibart) in the Journal for ImmunoTherapy of Cancer confirming its immunomodulatory effects.
FDA grants Chinese Shanghai Henlius Orphan Drug Designation in gastric cancer for Alligator’s out-licensed candidate HLX22.
Publication of Alligator’s Annual Report for 2024 on 27 March 2025, outlining operational and financial highlights.
FINANCIAL SUMMARY FOR Q1 2025
The financial summaries for the quarterly periods ending 31 March 2025 and 31 March 2024 are presented below.

All amounts in MSEK,
unless specified January – March
2025 January – March
2024
Net sales - 7.0
Operating profit/loss -43.7 -59.6
Profit/loss for the period -8.3 -62.8
Cash flow for the period -34.6 -26.2
Cash and cash equivalents 28.9 40.0
Earnings per share before and after dilution, SEK -1.1 -95.4
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Thursday, April 24 2025, at 2 p.m. CEST/ 8 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the January – March 2025 interim report, which will be followed by a Q&A session.

Incyte to Showcase New Data from its Oncology Portfolio at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

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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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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"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.