On May 31, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported detailed results from the global, randomized Phase 3 RASolute 302 clinical trial evaluating daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The results will be presented during a late-breaking Plenary Session (LBA5) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting at 3:21 p.m. CDT today and were published today in The New England Journal of Medicine.

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RAS, a key growth control switch in human cells, is the primary oncogenic driver of PDAC, a disease that is typically characterized by excessive RAS(ON) signaling in tumors with or without a mutant allele of RAS. Daraxonrasib is the first investigational agent in a novel class of RAS(ON) multi-selective inhibitors designed to address a diverse and broad spectrum of RAS variants. In the randomized Phase 3 RASolute 302 trial, once-daily oral daraxonrasib demonstrated unprecedented improvements in overall survival (OS) and progression-free survival (PFS) compared to standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. All primary and key secondary endpoints of the trial were met. Daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy.

"Revolution Medicines has been singularly focused on developing bold new targeted medicines for treating patients with RAS-driven cancers, which are some of the most aggressive and difficult-to-treat diseases in oncology. The data from the Phase 3 RASolute 302 trial clearly validate our pioneering, science-driven approach and add to the growing body of evidence underscoring the broad potential of RAS(ON) inhibition that we are testing across pancreatic cancer and other RAS-driven cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

"Daraxonrasib significantly elevates the survival bar in the treatment of one of the deadliest human cancers, while better preserving quality of life compared to chemotherapy. In this trial, daraxonrasib redefined treatment expectations in previously treated metastatic pancreatic cancer by reducing the risk of death by 60% and increasing median overall survival to more than one year, a result not previously reported in any Phase 3 clinical trial in any line of therapy for this disease. These striking results firmly support daraxonrasib as the new standard of care for patients with previously treated metastatic pancreatic cancer, and usher in a new era of RAS-targeted therapy for patients living with this disease," added Dr. Goldsmith.

"These results from the Phase 3 RASolute 302 trial of daraxonrasib represent a major milestone for patients facing metastatic pancreatic cancer," said Brian M. Wolpin, M.D., M.P.H., director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School, and principal investigator for the RASolute 302 trial. "For many patients, second line chemotherapy provides modest benefits, and new treatments delivering more durable tumor control have been urgently needed. In this global randomized trial, daraxonrasib, an oral RAS(ON) inhibitor, doubled median overall survival compared to standard of care chemotherapy for patients with previously treated metastatic pancreatic cancer. Importantly, this survival benefit was achieved with a generally manageable safety profile, highlighted by the low rate of treatment discontinuation due to treatment-related side effects. These results will change how scientists, clinicians, and patients think about treatment for pancreatic cancer, and support a new paradigm where RAS(ON) inhibition enters standard of care for patients with previously treated metastatic pancreatic adenocarcinoma."

Summary of Phase 3 RASolute 302 Clinical Trial Results

The trial enrolled 500 patients with previously treated metastatic PDAC, randomized to receive once-daily oral daraxonrasib (n=248) or investigator’s choice of four different cytotoxic chemotherapy regimens (n=252), which represent standard of care across the globe. At the February 10, 2026 data cutoff, median follow-up was 8.5 months (range, 3.2–15.9). The trial met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements versus chemotherapy in both the RAS G12 mutant population (daraxonrasib n=228; chemotherapy n=231) and the overall, or intent-to-treat (ITT), population, which included patients with or without an identified tumor RAS mutation.

Daraxonrasib resulted in a 60% reduction in the risk of death in both the RAS G12 and ITT populations. In the RAS G12 population, daraxonrasib demonstrated a hazard ratio (HR) of 0.40 (95% confidence interval [CI]: 0.30–0.54; p<0.0001), with a median OS of 13.2 months (95% CI: 10.0–not estimable [NE]) compared to 6.6 months (95% CI: 5.4–8.2) for chemotherapy. Consistent results were observed in the ITT population, which showed an HR of 0.40 (95% CI: 0.30–0.53; p<0.0001), with a median OS of 13.2 months (95% CI: 10.0–NE) for daraxonrasib compared to 6.7 months (95% CI: 5.8–8.0) for chemotherapy. Patients on daraxonrasib also showed significant improvements in PFS as assessed by a blinded independent central review. In the RAS G12 population, the HR for PFS was 0.45 (95% CI: 0.34–0.59; p<0.0001), with a median PFS of 7.3 months (95% CI: 6.3–8.1) for daraxonrasib compared to 3.5 months (95% CI: 2.9–3.8) for chemotherapy. Similarly, in the ITT population, the HR for PFS was 0.49 (95% CI: 0.38–0.64; p<0.0001), with a median PFS of 7.2 months (95% CI: 5.7–7.5) for daraxonrasib versus 3.6 months (95% CI: 2.9–4.2) for chemotherapy. Objective response rates were 33.2% with daraxonrasib compared to 11.8% with chemotherapy in the RAS G12 population, and 31.6% with daraxonrasib compared to 11.2% with chemotherapy in the ITT population.

Daraxonrasib was generally well tolerated with a manageable safety profile and no unexpected safety findings. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 43.6% of patients receiving daraxonrasib versus 57.5% of patients receiving chemotherapy. The most frequent Grade 3 or higher TRAEs occurring in at least 10% of patients who received daraxonrasib were rash (14%) and stomatitis (12%). In patients who received chemotherapy, the most common Grade 3 or higher TRAEs were neutropenia (28%), anemia (16%), and thrombocytopenia (10%). Treatment-related serious adverse events occurred in 10.8% of patients receiving daraxonrasib versus 18.7% receiving chemotherapy. One Grade 5 TRAE of pneumonitis was reported in the daraxonrasib arm (0.4%), and no Grade 5 TRAEs were reported in the chemotherapy arm. Discontinuation of therapy due to TRAEs occurred in 1.2% of patients receiving daraxonrasib, compared with 11.2% on chemotherapy. The median dose intensity for daraxonrasib was 93.1% and across chemotherapy regimens it was 65.3-95.0%.

The RASolute 302 trial also evaluated patient-reported outcomes as an important secondary outcome, given the high symptom burden that patients with metastatic PDAC experience. Daraxonrasib demonstrated a statistically significant and clinically meaningful delay in the time to deterioration in pain, global health status and quality of life when compared to standard of care chemotherapy. In the ITT population, the HR for time to deterioration in pain was 0.51 (95% CI: 0.37–0.71; p<0.0001), and the HR for global health status and quality of life was 0.60 (95% CI: 0.46–0.79; p=0.0002).

Revolution Medicines intends to submit these data to global regulatory authorities, including to the U.S. Food and Drug Administration (FDA) as part of a New Drug Application under a Commissioner’s National Priority Voucher. In addition, the U.S. FDA recently authorized the company to initiate an expanded access treatment protocol (EAP) for daraxonrasib for eligible patients. Additional details on the daraxonrasib EAP are available here.

Company Webcast

Revolution Medicines will host a webcast on May 31, 2026, at 6:00 p.m. Central Time (7:00 p.m. Eastern Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About the RASolute 302 Clinical Trial

RASolute 302 (NCT06625320) is a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg daraxonrasib once daily or investigator’s choice of four different cytotoxic chemotherapy regimens, which represent standard of care across the globe. The trial enrolled patients with metastatic PDAC harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as patients without an identified tumor RAS mutation (wild type).

The primary endpoints of the RASolute 302 trial were progression-free survival (PFS), as assessed by a Blinded Independent Central Review according to RECIST 1.1, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints included PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life.

About Daraxonrasib

Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent inhibitor that is not approved by any regulatory authority, including in the United States or Europe. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.

Daraxonrasib is designed to target cancers driven by a broad range of common RAS genotypes, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. In addition to the RASolute 302 trial, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC and metastatic RAS mutant NSCLC.

Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma

Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.

(Press release, Revolution Medicines, MAY 31, 2026, View Source [SID1234666252])

On May 31, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

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Key findings are detailed below.

Oral Presentation: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; Date/Time: May 31, 2026, 9:12 AM CDT; Location: Arie Crown Theater; Abstract: 2504; Presenter: Joseph Sacco, PhD, MBChB

The Phase 1 first-in-human trial enrolled 85 heavily pretreated patients with advanced solid tumors, including uveal melanoma, colorectal cancer, head and neck cancers, pancreatic cancer, cutaneous melanoma, and sarcoma.
Patients had received a median of 2 prior lines of systemic therapy; 42% had received prior immune checkpoint inhibitor (ICI) therapy
RP2 monotherapy achieved an objective response rate (ORR) of 19.0% (4/21 evaluable patients), with responses observed in uveal melanoma, esophagogastric adenocarcinoma, chordoma, and mucoepidermoid carcinoma
RP2 in combination with nivolumab achieved an ORR of 19.1% (9/47 evaluable patients), with a disease control rate of 48.9%
In uveal melanoma, where a randomized Phase 2/3 trial is enrolling, the pooled ORR (RP2 in combination with nivolumab and RP2 monotherapy) was 33.3%
Responses were durable: median duration of response was not reached in the monotherapy group (range: 11.5–27.3+ months) and was 22.1 months in the combination group (range: 2.8–35.2+ months)
Tumor regression was observed in both injected and non-injected lesions, including in all 3 monotherapy responders who had non-injected lesions, demonstrating a systemic immune response beyond the site of injection
Translational analyses demonstrated that RP2 reprogrammed tumors from immunologically "cold" to immune-inflamed, upregulated T-cell cytotoxicity and antigen presentation pathways, and significantly expanded HSV-1-specific and tumor-associated (MAGE) TCR clones, confirming the intended mechanism of action and systemic immune engagement.
RP2 monotherapy and RP2 in combination with nivolumab were well tolerated with no unexpected toxicities, no Grade 4 or 5 treatment-related adverse events, and no increase in immune-related adverse events beyond the expected profile of nivolumab alone; the most common events were low-grade pyrexia, chills, and fatigue, consistent with systemic immune activation
Based on these results, RP2 is being evaluated in combination with nivolumab in patients with metastatic uveal melanoma in a randomized Phase 2/3 trial (NCT06581406)
About RP2
RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, MAY 31, 2026, View Source [SID1234666251])

On May 31, 2026 Novartis reported results showing consistent radiographic progression-free survival (rPFS) improvement across key subgroups with Pluvicto (lutetium Lu 177 vipivotide tetraxetan) plus standard of care (SoC; androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) compared to SoC alone in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). These PSMAddition data were presented as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The subgroup analysis evaluated outcomes by disease volume (high or low) and disease presentation (de novo or recurrent mHSPC). Pluvicto demonstrated a similar rPFS improvement across key subgroups, consistent with the previously reported primary endpoint showing a 28% reduction in the risk of radiographic progression or death (HR 0.72; 95% CI: 0.58, 0.90). Secondary endpoints for disease progression were also consistent. Together, these data support use of Pluvicto as early as PSMA+ metastatic prostate cancer diagnosis.

Subgroup rPFS hazard ratio for Pluvicto arm vs. control arm
Overall (n=1,144) 0.72 (0.58 – 0.90)
High volume disease (n=779) 0.72 (0.56 – 0.92)
Low volume disease (n=365) 0.73 (0.42 – 1.27)
De novo (n=572) 0.74 (0.54 – 1.01)
Recurrent (n=523) 0.74 (0.53 – 1.04)
Disease volume per CHAARTED criteria; data from second interim analysis for rPFS, DCO 13 Jan 2025

"Metastatic hormone-sensitive prostate cancer is a heterogeneous disease, with disease burden and presentation often dictating how aggressively a patient’s cancer will progress," said Fred Saad, Professor and Chairman, Department of Surgery, University of Montreal. "The consistent findings demonstrated with Pluvicto across key subgroups, regardless of initial presentation or disease volume, reinforce its potential as a cornerstone of early treatment for a broad range of patients."

The safety profile was generally consistent across subgroups within each treatment arm, with similar incidence of adverse events (AEs). In PSMAddition, Grade ≥3 AEs were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared to 43% on SoC alone. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia.

More than 186,000 men are diagnosed annually with mHSPC, now also known as metastatic androgen pathway modulation-naïve/sensitive prostate cancer (mAPMN/S), globally*1. Most patients progress to castration-resistant, or modulation-resistant (mAPMR) disease within 20 months2,3. The PSMA biomarker is present in more than 80% of patients with prostate cancer4-8.

Novartis has filed regulatory submissions in the US, China and Japan based on results from PSMAddition, with first decisions expected in H2 2026.

Promising Phase 1 data from AcTION for actinium-based RLT 225Ac-PSMA-617
Novartis also presented data for its actinium-based RLT, 225Ac-PSMA-617, from the Phase 1 AcTION trial. The data showed promising early antitumor activity with PSA declines and radiographic responses, as well as a manageable safety profile which supports further clinical development in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

"Novartis helped redefine treatment for metastatic prostate cancer with Pluvicto, and we are continuing to push the bar even higher," said Mark Rutstein, Global Head of Oncology Development at Novartis. "Our actinium program represents the next frontier in radioligand therapy, and with two Phase 3 trials underway, we are working to extend the promise of RLTs to more patients."

225Ac-PSMA-617 is an investigational actinium-based RLT that targets PSMA with a proven ligand to deliver short-ranged, high-energy alpha-particle radiation directly to prostate cancer cells. 225Ac-PSMA-617 is designed to induce potent tumor cytotoxicity while minimizing exposure to surrounding healthy tissues, reflecting Novartis’ strategy to advance differentiated RLTs across multiple disease stages.

Novartis is enrolling two Phase 3 trials for 225Ac-PSMA-617:

PSMAcTION evaluating 225Ac-PSMA-617 in mCRPC after Pluvicto, chemotherapy and ARPI
AcTFirst evaluating 225Ac-PSMA-617 in frontline mCRPC
Radioligand Therapy (RLT) at Novartis
Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation, RLT is designed to deliver treatment directly to target cells anywhere in the body.

As a global leader in this space, Novartis has built integrated capabilities across research, manufacturing, logistics, and patient and provider support to help ensure approved RLTs reach patients reliably and efficiently. Novartis is investigating a broad portfolio of isotopes, ligands, and combination therapies to expand the use of RLT beyond prostate and neuroendocrine tumors.

(Press release, Novartis, MAY 31, 2026, View Source [SID1234666249])

On May 31, 2026 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported updated results from its Phase 1/2 trial evaluating brenetafusp in patients with heavily pretreated advanced melanoma. The data is presented in a poster at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"I am pleased to present these updated brenetafusp data at ASCO (Free ASCO Whitepaper). Patients with advanced melanoma who progress on anti-PD-1 therapy have limited options, and seeing meaningful disease control in heavily pretreated patients is genuinely promising. These results support continued evaluation of brenetafusp in advanced melanoma," said Professor Georgina Long, Medical Director, Melanoma Institute Australia, The University of Sydney.

"These data with brenetafusp in heavily pretreated advanced melanoma show consistent responses and survival even in those with poor prognosis, including patients with primary PD-1 resistance," said Mohammed Dar, Chief Medical Officer of Immunocore. "These data also reinforce our confidence in the potential of brenetafusp at the dose of 160 mcg in combination with nivolumab in first-line advanced melanoma, in the ongoing Phase 3 PRISM-MEL-301 trial."

Phase 1/2 efficacy data

In the 66 patients treated with brenetafusp monotherapy (target doses 20-320 mcg), the median overall survival (OS) was 14.3 months (95% CI: 11.3-20.4; median follow up of 22.4 months) with a landmark OS rate of 87% at 6 months and 57% at 12 months. The disease control rate (DCR = partial responses and stable diseases) was 52%, while the overall response rate (ORR) was 12%.

Multiple measures of clinical benefit (6-month OS, DCR, ORR, tumor reduction) were numerically higher for patients treated with the 160 mcg dose – despite worse baseline prognostic factors compared to those treated with 40 mcg. These data support selection of 160 mcg for the ongoing Phase 3 trial evaluating brenetafusp + nivolumab vs. standard nivolumab regimens (NCT06112314) in first-line advanced melanoma. The safety profile was similar at both doses.

Median OS was 14.7 months for patients with primary PD-1 resistance, defined as progression within 6 months of starting the first regimen containing anti-PD1. Despite these patients having primary PD-1 resistance, the median OS was similar to all monotherapy patients (14.3 months).

In exploratory analyses, circulating tumor DNA (ctDNA) response in patients with PD-1 primary resistance was numerically higher (53%; 8/15) compared to the overall group (38%; 19/50). Treatment outcome was not impacted by PD-L1 status and was shown, in this exploratory analysis, to be associated with tumor expression of beta 2 microglobulin – a protein involved in antigen presentation – and baseline peripheral blood T cell fitness, which has been shown to be better in earlier lines of therapy.

In the 10 patients treated with brenetafusp in combination with pembrolizumab, the data showed numerically higher ORR and DCR compared to monotherapy, with efficacy also reported in patients with PD-1 primary resistance.

Phase 1/2 safety data

Brenetafusp was generally well tolerated, showing a predictable, mechanism-driven safety profile as monotherapy and in combination. The most common treatment-related adverse events (TRAEs) (≥20%) – which were reversible and attenuated over time – included CRS (56%; predominantly low grade, reversible, and attenuated over time), rash (44%), pyrexia (44%), chills (38%), fatigue (31%), decreased lymphocyte count (38%), nausea (25%), and pruritus (44%). The most frequent Grade 3-4 TRAE was transient decreased lymphocyte count (25%). There were three TRAEs that led to treatment discontinuation (two monotherapy patients and one combination patient).

Phase 1/2 trial overview

The Phase 1/2 trial (NCT04262466; EudraCT 2019-004046-16) enrolled patients with unresectable or metastatic melanoma who were HLA-A*02:01-positive (central testing) and previously treated with anti-PD-(L)1 therapy. Brenetafusp was administered as a weekly IV infusion with step dosing to a target dose. Tumor response was assessed by RECIST every 9 weeks; ctDNA was assessed every three weeks.

Second poster: Effect of IL7 on T cell fitness and ImmTAC anti-tumor activity

In a second poster presented during ASCO (Free ASCO Whitepaper) 2026, the Company built on previously disclosed data regarding the importance of T cell fitness for the efficacy of ImmTAC molecules. The new data demonstrated the anti-tumor activity of these therapies may increase when combined with IL7 in vitro. This study showed that IL7 treatment expanded naïve/stem-like memory T cells, enhanced ImmTAC-mediated T cell induction of IFNγ secretion and tumor killing, as well as reduced immune checkpoint receptor expression and T cell exhaustion. Additionally, a single dose of IL7 resulted in a sustained increase in T cell fitness of cancer patients. Taken together, the in vitro and in vivo data are consistent with the hypothesis that a combination with IL7 may increase the anti-tumor activity of ImmTAC therapies.

Presentations details (ASCO 2026)

Title: Phase 1 evaluation of the PRAME-targeted ImmTAC brenetafusp in advanced melanoma (Mel). (Abstract number: 9527)
Session: Melanoma/Skin Cancers (Poster Board: 243)
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Title: Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T cell fitness in patients (Abstract number: 2662)
Session: Developmental Therapeutics – Immunotherapy (Poster Board: 452)
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT

(Press release, Immunocore, MAY 31, 2026, View Source [SID1234666248])

On May 31, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, reported the presentation of extended data from the ongoing Phase 1 clinical trial evaluating its TCR bispecific (TCER) candidate IMA401 targeting MAGEA4/8 in heavily pretreated patients with solid tumors, including head and neck cancer and lung cancer, in an oral presentation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL, USA. The data show a consistent and favorable tolerability profile across multiple tumor types and encouraging anti-tumor activity at the recommended Phase 2 dose (RP2D) with or without the immune checkpoint inhibitor (ICI) pembrolizumab. Results from the Phase 1 study are being published simultaneously in Nature Medicine.

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Data from the ongoing Phase 1 study of IMA401 will be presented on May 31, 2026, during the Developmental Therapeutics Session – Immunotherapy from 8:00-11:00 am CDT by Martin Wermke, M.D., TU Dresden University of Technology, NCT/UCC Early Clinical Trial Unit, Dresden, Germany (Abstract ID: 2507). The slides are available in the ‘Events & Presentations’ section of the Investor & Media page on the Company’s website.

Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics, said, "The IMA401 clinical data represent an important step forward for our next-generation, off-the-shelf TCER platform and reinforce the potential of this modality to address both advanced and earlier-stage solid tumors. Building on the encouraging clinical activity and supportive preclinical findings, we believe IMA401 may have even greater potential in combination with IMA402, our PRAME-directed bispecific. The initiation of the IMA401/IMA402 combination cohort in squamous cell non-small cell lung cancer marks a milestone toward broadening patient reach and delivering meaningful clinical benefit for patients with significant unmet needs."

Based on the clinical data for IMA401, including the initial clinical signal in squamous cell non-small cell lung cancer (sqNSCLC), as well as preclinical proof-of-concept data and clinical data for IMA402, Immatics has initiated enrollment in a Phase 1 cohort at multiple clinical trial sites evaluating IMA401 targeting MAGEA4/8 in combination with IMA402 targeting PRAME in sqNSCLC. The dual targeting approach is designed to broaden patient coverage and potentially enhance anti-tumor activity by addressing two highly prevalent cancer targets, with sqNSCLC as the first indication, and further development potential for many others. Based on combined target prevalence, more than 90% of patients with sqNSCLC express PRAME and/or MAGEA4/8. The current addressable patient population for metastatic sqNSCLC in the United States and EU5 is estimated at approximately 40,000 patients per year. First data from the IMA401/IMA402 combination cohort are expected in 2027.

Highlights of Immatics’ clinical data on IMA401

Patient population: Heavily pretreated, highly heterogeneous patient population

As of the data cutoff on March 2, 2026, 61 patients with recurrent and/or refractory solid tumors across >15 different tumor types were treated with IMA401 with or without an immune checkpoint inhibitor (ICI, pembrolizumab) in a Phase 1 dose-escalation basket trial (NCT05359445).
Patients were heavily pretreated with a median of three prior lines of systemic treatment (range: 1-8).
44 patients were treated at RP2D (1-2 mg), with 32 receiving monotherapy and 12 receiving the combination of IMA401 and pembrolizumab. Among these patients, head and neck cancer represented the largest subgroup treated at RP2D (n=14).

Safety: Favorable tolerability at RP2D supporting broad combinability of IMA401

The tolerability profile of IMA401 with or without pembrolizumab was consistent across patient populations.
The most frequent clinically relevant treatment-related adverse events (TRAE) observed across dose levels were low-grade cytokine release syndrome (CRS) (38% G1-2, no ≥ Grade 3), expected and transient lymphopenia (33%), consistent with the mechanism of action, and neutropenia (31%). Within the RP2D range of 1-2 mg, neutropenia was mostly transient and manageable.
Notably, no immune effector cell-associated neurotoxicity syndrome (ICANS) was observed.
Tolerability of IMA401 at RP2D in combination with pembrolizumab was consistent with IMA401 as a monotherapy at RP2D, with no overlapping and/or additive toxicity observed.
Tolerability profile of IMA401, both as a monotherapy and with pembrolizumab, supports broad combination potential of IMA401.

Anti-tumor activity and durability: Promising clinical activity with deep and durable responses
Patients treated with IMA401 at RP2D as a monotherapy or in combination with pembrolizumab demonstrated clinical activity across multiple solid tumor indications, including melanoma, sqNSCLC, head and neck cancer and others:

Head and neck cancer (largest patient subgroup treated at RP2D): confirmed objective response rate (cORR) of 29% (4/14), disease control rate (DCR) of 64% (9/14), median duration of response (mDOR) of 8.8 months. The 12-month overall survival (OS) rate was 63% and the six-month progression-free survival (PFS) rate was 43%. All responders achieved deep tumor reduction ranging from 60-100% and three of four responders were ongoing at data cutoff.
Melanoma: cORR of 33% (2/6), DCR of 67% (4/6); both confirmed responses lasted beyond six months post treatment, with one ongoing for >2.5 years.
sqNSCLC: A presented patient case highlighted a patient with ICI-resistant sqNSCLC who received IMA401 plus pembrolizumab in fifth-line (prior best overall response: stable disease) and achieved a partial response with shrinkage of all target lesions.

Preclinical data: Supporting broad patient coverage and potential synergistic activity of IMA401/IMA402 combination

Target expression data from analyzed tumor samples showed that >90% of patients with sqNSCLC are positive for PRAME and/or MAGEA4/8, and ~60% of patients with sqNSCLC are positive for both targets, suggesting that a combination therapy against both targets could boost anti-tumor activity and counteract potential tumor escape mechanisms.
IMA401/IMA402 combination demonstrated synergistic anti-tumor activity in MAGEA4/8 and PRAME double-positive tumor cell lines.
Data on the IMA401 Phase 1 trial are published simultaneously in Nature Medicine.

About Immatics TCR Bispecifics (TCER)
Immatics’ next-generation half-life extended TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics’ proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER format comprises an Fc part that confers half-life extension, stability, and manufacturability. TCER molecules are "off-the-shelf" biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and can reach a large patient population without the need for specialized medical centers.

About IMA401 MAGEA4/8 Bispecific
IMA401 is a molecule from Immatics’ TCR bispecifics pipeline that targets an HLA-A*02:01-presented peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT and is presented at a 5-fold higher target density (copy number per tumor cell) than the MAGEA4 peptide targeted in other clinical trials. IMA401 is currently being evaluated in a Phase 1 basket trial in patients with MAGEA4/8-positive solid tumors. The MAGEA4/8 peptide has a high prevalence in several solid tumor indications such as head and neck squamous cell carcinoma (HNSCC), squamous cell non-small cell lung cancer (sqNSCLC), as well as melanoma and other solid cancer types.

About IMA402 PRAME Bispecific
IMA402 is a molecule from Immatics’ TCR bispecifics (TCER) pipeline directed against an HLA-A*02:01-presented peptide derived from PRAME. IMA402 is currently being evaluated in a Phase 1 trial in patients with solid tumors expressing PRAME. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies.

(Press release, Immatics, MAY 31, 2026, View Source [SID1234666247])