Incyte Highlights New Phase 3 Tafasitamab Data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2026 Incyte (Nasdaq:INCY) reported that full results from the Phase 3 pivotal study evaluating tafasitamab (Monjuvi/Minjuvi) in first-line diffuse large b-cell lymphoma (DLBCL) will be featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago.

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"The positive Phase 3 frontMIND results for tafasitamab in patients with newly diagnosed diffuse large B-cell lymphoma highlight Incyte’s continued focus on advancing novel differentiated approaches with the potential to meaningfully impact patients," said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. "We look forward to sharing the full data at ASCO (Free ASCO Whitepaper), and to progressing our pipeline."

Presentation details:

frontMIND: Phase 3 Study of tafasitamab (Tafa) Plus lenalidomide (Len) and R-CHOP for Patients (pts) with Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
(Abstract #7000. Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia. May 30, 4:00 – 7:00 p.m. ET (3:00 – 6:00 p.m. CDT))

More information regarding the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at: View Source

About Tafasitamab (Monjuvi/Minjuvi)

Tafasitamab (Monjuvi/Minjuvi) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

(Press release, Incyte, APR 21, 2026, View Source [SID1234664647])

Obsidian Therapeutics to Present OBX-115 Phase 2 Clinical Data in Advanced Melanoma in Oral Presentation at 2026 ASCO Annual Meeting

On April 21, 2026 Obsidian Therapeutics, Inc., a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported an oral presentation of Phase 2 results in patients with advanced melanoma from the Phase 1/2 Agni-01 multicenter study of OBX-115, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, May 29–June 2, 2026.

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Oral Presentation Details:

Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients with advanced melanoma that has progressed on/after immune checkpoint inhibitors (ICI): Phase 2 results
Session Type/Title: Oral Abstract Session – Melanoma/Skin Cancers
Date: Monday, June 1
Abstract Number: 9507
Speaker/Lead Author: Allison S Betof, Division of Oncology, Stanford University School of Medicine, Stanford, CA
Clinical Trial Identifier: NCT06060613

About OBX-115
Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

(Press release, Obsidian Therapeutics, APR 21, 2026, View Source [SID1234664646])

Tubulis to Present Phase I/IIa Trial Data for ADC Candidate TUB-040 in Platinum-resistant Ovarian Cancer in Rapid Oral Presentation at ASCO 2026

On April 21, 2026 Tubulis reported that an abstract covering current clinical trial data from its ongoing Phase I/IIa NAPISTAR 1-01 trial (NCT06303505) has been accepted for a rapid oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, being held May 29 – June 2, 2026, in Chicago. The presentation by Prof. Dr. Toon Van Gorp, clinical investigator of the study, will provide an update of maturing data from the ongoing dose escalation part of the ovarian cancer cohort.

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Details of the oral presentation:

Title: NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC)
Presenter: Dr. Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven, Belgium
Session Category and Title: Rapid Oral Abstract Session: Gynecologic Cancer
Session Date and Time: May 30, 2026; 08:00 – 09:30 AM CDT
Location: McCormic Place, E450a
Abstract Number: 5513

About TUB-040 and the Tubutecan Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against NaPi2b, an antigen highly overexpressed in ovarian cancer, lung adenocarcinoma, and endometrial cancer. It consists of an IgG1 antibody targeting NaPi2b equipped with Tubulis’ proprietary Tubutecan technology, connecting the Topoisomerase I inhibitor, exatecan, through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. Based on novel chemistry for cysteine-selective conjugation, the technology enables the development of stable, highly targeted ADCs optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. The candidate has already demonstrated robust clinical activity with a favorable safety profile as monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC), reported at ESMO (Free ESMO Whitepaper) 2025. It is currently being further investigated in a multicenter Phase I/IIa study (NAPISTAR1-01, NCT06303505) in PROC and relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

(Press release, Tubulis, APR 21, 2026, View Source [SID1234664645])

Immunome Announces Oral Presentation of Phase 3 RINGSIDE Data at 2026 ASCO Annual Meeting

On April 21, 2026 Immunome, Inc. ("Immunome") (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported that data from RINGSIDE, its global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, has been selected for presentation in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2, 2026, in Chicago.

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"The selection of the Phase 3 RINGSIDE trial for oral presentation at ASCO (Free ASCO Whitepaper) reflects the importance of advancing new treatment options for patients with desmoid tumors," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We look forward to sharing detailed results that build on the positive topline data reported in December 2025."

Oral Presentation Details

Abstract Title

RINGSIDE: A phase 3 randomized, placebo-controlled trial of varegacestat for treatment of progressing desmoid tumors

Session Type/Title

Oral Abstract Session – Sarcoma

Date and Time

May 30, 2026, 3:00 PM–6:00 PM CDT

Presenter

Mrinal M. Gounder, M.D., Memorial Sloan Kettering Cancer Center

Abstract Number

11506

About the RINGSIDE Trial

The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (NCT04871282) evaluated the efficacy and safety of varegacestat in patients with progressing desmoid tumors. A total of 156 patients were randomized to receive varegacestat 1.2 mg daily or placebo until disease progression or death, representing the largest randomized study in this population. The primary endpoint of the trial was progression-free survival as assessed by blinded independent central review. Statistically controlled secondary endpoints were confirmed ORR using RECIST v1.1 and change in tumor volume at week 24, both determined by blinded independent central review, as well as change in pain intensity at week 12 as determined using a patient reported outcome instrument. Additional secondary endpoints included duration of response, best reduction in tumor volume, patient-reported outcomes, and safety and tolerability. RINGSIDE includes an open-label extension phase, which is ongoing.

About Varegacestat

Varegacestat (formerly AL102) is an investigational, oral, once-daily gamma secretase inhibitor. In December 2025, Immunome reported positive topline results for the Phase 3 RINGSIDE trial of varegacestat in adults with progressing desmoid tumors. Immunome plans to submit a New Drug Application for varegacestat to the U.S. Food and Drug Administration in Q2 2026.

(Press release, Immunome, APR 21, 2026, View Source [SID1234664644])

Pfizer Showcases Oncology Innovation and Next-Generation Pipeline at ASCO 2026

On April 21, 2026 Pfizer Inc. (NYSE: PFE) reported it will present new data across its diverse, industry-leading Oncology pipeline and portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 29 – June 2, 2026, in Chicago. Data from more than 40 company-sponsored, investigator-sponsored and collaborative research abstracts, including three late-breaking sessions and eight oral and rapid oral presentations, will be shared. These data highlight Pfizer’s leadership in establishing potential new standards of care across multiple cancer types and its next-generation pipeline of novel targets and combination strategies designed to extend impact into broader patient populations and earlier lines of therapy.

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"For people living with cancer and their families, every moment matters. We are moving with urgency to drive advances that have the potential to change standards of care – and striving to bring new, innovative options to patients in earlier lines of therapy," said Jeff Legos, Chief Oncology Officer, Pfizer. "Our progress is evident in the data presented at ASCO (Free ASCO Whitepaper) this year, which span our portfolio of established therapies, as well as next-generation, early-stage clinical research from one of the industry’s largest oncology R&D programs. Together, these results reinforce our ability to advance breakthroughs that may redefine clinical practice and change the lives of people with cancer."

Key highlights of Pfizer’s presence at ASCO (Free ASCO Whitepaper) include:

Sharing new evidence for standard-of-care therapies in certain types of biomarker-driven colorectal and lung cancers

Seven-year update from the pivotal Phase 3 CROWN study further supports LORBRENA (lorlatinib) as a guideline-recommended first-line treatment for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).
Late-breaking presentation of progression-free survival (PFS) and overall survival (OS) data from Cohort 3 of the BREAKWATER* trial evaluating BRAFTOVI (encorafenib) in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin and irinotecan) as a first-line regimen for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). These pivotal data further establish the benefit of this BRAFTOVI regimen following the U.S. Food and Drug Administration (FDA) full approval and the topline results announcement for objective response rate (ORR) from this Cohort earlier this year.
Showcasing data on potential benefit of treatments in earlier lines of therapy for prostate and breast cancers

Late-breaking presentation from the Phase 3 TALAPRO-3 study will highlight clinically meaningful radiographic progression-free survival (rPFS) benefit for TALZENNA (talazoparib) plus XTANDI** (enzalutamide) in metastatic castration‑sensitive prostate cancer (mCSPC) patients with homologous recombination repair gene alterations, with effects consistent across subgroups and a strong OS trend. These data follow the announcement of topline results in March 2026 and support the potential of TALZENNA plus XTANDI to deliver benefit earlier in the disease course.
Additional efficacy and safety outcomes by stratified subgroups from the Phase 3 HER2CLIMB-05 study investigating TUKYSA (tucatinib) in combination with trastuzumab and pertuzumab as first-line maintenance therapy for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). These results support TUKYSA’s potential use as part of a chemotherapy-free, first-line maintenance strategy for HER2+ MBC.
Advancing next-generation pipeline of novel mechanisms and differentiated combinations across solid tumors

Updated Phase 2 data for PF‑08634404 (PF’4404), a novel bispecific antibody targeting PD-1 and VEGF, as monotherapy in first-line PD-L1-expressing NSCLC. PF’4404 is being developed as a potential backbone therapy across tumor types, including an ongoing Symbiotic-Lung-01 Phase 3 study in combination with chemotherapy in first-line NSCLC regardless of PD-L1 expression and an ongoing Symbiotic-GI-03 Phase 3 study in first-line mCRC.
Updated results from a Phase 1 study of sigvotatug vedotin (SV), a novel integrin β6 (IB6)–directed ADC, in combination with pembrolizumab in NSCLC. These data support the ongoing SigVie-003 Phase 3 study of SV in combination with pembrolizumab in first-line NSCLC. An additional ongoing Phase 3 study, SigVie-002, is evaluating SV monotherapy in patients previously treated for advanced NSCLC.
The first results from a Phase 2 study of neoadjuvant atirmociclib, a highly selective CDK4 inhibitor, in combination with letrozole versus letrozole alone in people with hormone receptor-positive (HR+), HER2- breast cancer. Atirmociclib is being developed as a potential first-in-class, next-generation cell cycle inhibitor backbone for HR+, HER2- breast cancer in the early adjuvant and first-line metastatic setting.
Findings from a Phase 1b study of a brain-penetrant MEK inhibitor, PF-07799544 (polfurmetinib), plus a next-generation BRAF inhibitor, PF-07799933 (claturafenib), in advanced BRAF-mutant melanoma.
Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here.

LUNG CANCER

Oral Presentation (Abstract 8502)

May 29, 2026 1:00 PM-4:00 PM CDT

Lorlatinib vs crizotinib as first-line treatment for advanced ALK+ non-small cell lung cancer: 7-year update from the phase 3 CROWN study

Mok et al

Rapid Oral Presentation (Abstract 8514)

May 30, 2026 1:15 PM-2:45 PM CDT

Updated results from a phase 2 trial of SSGJ-707 (PF-08634404), a PD-1/VEGF bispecific antibody, as monotherapy in patients with advanced non-small cell lung cancer (NSCLC)

Wu et al

Poster Presentation (Abstract 8522)

May 31, 2026 9:00 AM-12:00 PM CDT

Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody-drug conjugate (ADC), plus pembrolizumab: updated results from phase 1 study (SGNB6A-001)

Jaime et al

Poster Presentation (Abstract 8609)

May 31, 2026 9:00 AM-12:00 PM CDT

Reduction in circulating tumor DNA (ctDNA) significantly correlates with radiographic response and tumor PD-L1 expression in a phase 1 study of PDL1V (PF-08046054) in patients with non-small cell lung cancer (NSCLC)

Saleh et al

COLORECTAL CANCER

Oral Presentation (Abstract LBA3503)

May 31, 2026 8:00 AM-11:00 AM CDT

BREAKWATER: Progression-free survival analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC) [LBA]

Kopetz et al

BREAST CANCER

Oral Presentation (Abstract 1005)

June 2, 2026 9:45 AM-12:45 PM CDT

Efficacy and safety of tucatinib (TUC) vs placebo (PBO) combined with trastuzumab and pertuzumab (HP) as maintenance therapy for HER2+ metastatic breast cancer (MBC) by stratified randomized subgroups

Hamilton et al

Rapid Oral Presentation (Abstract LBA1018)

May 31, 2026 11:30 AM-1:00 PM CDT

Palbociclib plus Tamoxifen ± goserelin in women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer (BC): PATHWAY, an Asian international double-blind randomized phase 3 trial: Final Overall Survival (OS) analysis [LBA]

Lu et al

Poster Presentation (Abstract 518)

June 1, 2026 1:30 PM-4:30 PM CDT

Neoadjuvant atirmociclib plus letrozole versus letrozole alone in women with HR+/HER2− breast cancer: results from FOURLIGHT-2, a randomized phase 2 window of opportunity study

Goel et al

Poster Presentation (Abstract 1042)

June 1, 2026 1:30 PM-4:30 PM CDT

Tucatinib (TUC) combined with trastuzumab and pertuzumab (HP) as first-line (1L) maintenance therapy for HER2+ metastatic breast cancer (MBC): an in-depth safety analysis of HER2CLIMB-05

Dieras et al

Poster Presentation (Abstract 1068)

June 1, 2026 1:30 PM-4:30 PM CDT

Long-term safety and adverse event (AE) management in patients with ER+/HER2− metastatic breast cancer (mBC) receiving prifestrastat, a first-in-class KAT6 inhibitor, in combination with fulvestrant

Layman et al

BLADDER/GENITOURINARY CANCERS

Oral Presentation (Abstract LBA5007)

May 30, 2026 3:00 PM-6:00 PM CDT

TALAPRO-3: Talazoparib (TALA) + enzalutamide (ENZA) compared with placebo (PBO) + ENZA for the treatment of patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations [LBA]

Agarwal et al

Oral Presentation (Abstract 4507)

May 29, 2026 2:45 PM-5:45 PM CDT

Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the phase 3 EV-302 study

Powles et al

Oral Presentation (Abstract 4510)

May 30, 2026 8:00 AM-9:30 AM CDT

Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: phase 3 KEYNOTE-905 study [MSD led]

O’Donnell et al

Oral Presentation (Abstract 5006)

May 30, 2026 3:00 PM-6:00 PM CDT

Final results from ZZFIRST: a randomized phase 2 trial of enzalutamide (EZ) and talazoparib (TALA) in metastatic hormone-naïve prostate cancer (mHNPC)

Mateo et al

Poster Presentation (Abstract 4613)

May 31, 2026 9:00 AM-12:00 PM CDT

Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants with cisplatin-ineligible muscle-invasive bladder cancer (MIBC): An analysis of clinically relevant subgroups in KEYNOTE-905 [MSD led]

Adra et al

Poster Presentation (Abstract 5043)

May 31, 2026 9:00 AM-12:00 PM CDT

Impact of baseline demographics on therapy management in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with talazoparib (TALA) + enzalutamide (ENZA) in the TALAPRO-2 study: extended follow-up

De Giorgi et al

MELANOMA

Rapid Oral Presentation (Abstract 9512)

May 30, 2026 4:30 PM-6:00 PM CDT

Phase 1b study of a brain-penetrant MEK inhibitor, PF-07799544, plus next-generation BRAF dimer inhibitor, PF-07799933, in advanced BRAF-mutant melanoma

Chen et al

MULTIPLE MYELOMA

Oral Presentation (Abstract 7500)

May 29, 2026 2:45 PM-5:45 PM CDT

Safety and efficacy of elranatamab as early intervention in patients with high-risk smoldering myeloma: First results from the phase 2 ERASMM (EMN34) study

Touzeau et al

OTHER GYNECOLOGICAL CANCERS

Poster Presentation (Abstract 5627)

June 1, 2026 9:00 AM-12:00 PM CDT

A phase 2 study evaluating SSGJ-707 (PF-08634404), a PD-1/VEGF bispecific antibody, + chemotherapy (chemo) in patients (pts) with first-line (1L) advanced/recurrent endometrial cancer (EC)

(Press release, Pfizer, APR 21, 2026, View Source [SID1234664643])