On April 21, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that four abstracts highlighting botensilimab (BOT), alone or in combination with balstilimab (BAL), have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2, 2026, in Chicago, Illinois.

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The accepted abstracts reflect continued progress of Agenus’ botensilimab and balstilimab immunotherapy program across colorectal cancer, melanoma, and translational research. They include the first presentation of Phase 2 clinical data for BOT with or without BAL in advanced cutaneous melanoma refractory or resistant to anti–PD-(L)1 therapy, with or without prior CTLA-4 inhibition, as well as a translational biomarker abstract evaluating an artificial intelligence foundation model in solid tumors and two trials-in-progress posters in colorectal cancer.

"Our presence at ASCO (Free ASCO Whitepaper) reflects strong momentum across the botensilimab and balstilimab program. From the first Phase 2 melanoma presentation to important colorectal cancer trial updates and innovative translational biomarker research, these presentations underscore our focus on delivering new immunotherapy options to patients who need them most," said Garo H. Armen, PhD, Chairman and CEO of Agenus.

Presentation Details:

Abstract Title: Botensilimab (BOT) ± balstilimab (BAL) in patients (pts) with advanced cutaneous melanoma (cMEL) refractory/resistant (R/R) to anti–PD-(L)1 ± CTLA-4: A phase 2 trial
Abstract No.: 9543
Presenter: Michael Atkins MD; Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Session Title: Poster Session – Melanoma/Skin Cancers
Location: Hall A – Posters and Exhibits
Poster Board: 259
Date/Time: May 31, 2026, 9:00 AM–12:00 PM CDT

Abstract Title: Artificial intelligence (AI) foundation model as a predictor of efficacy of next-generation checkpoint inhibition with botensilimab (BOT) + balstilimab (BAL) in solid tumors using pretreatment H&E images
Abstract No.: 2535
Presenter: Ryan Dalton, Noetik
Session Title: Poster Session – Developmental Therapeutics—Immunotherapy
Location: Hall A – Posters and Exhibits
Poster Board: 325
Date/Time: May 30, 2026, 1:30 PM–4:30 PM CDT

Abstract Title: The CO.33/BATTMAN trial: A phase 3 randomized study of botensilimab + balstilimab versus best supportive care in chemo refractory unresectable colorectal adenocarcinoma that is not dMMR/MSI-H
Abstract No.: TPS3676
Presenter: Jonathan Loree MD; BC Cancer; Canadian Cancer Trials Group, Queen’s University
Session Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal
Location: Hall A – Posters and Exhibits
Poster Board: 441a
Date/Time: May 30, 2026, 9:00 AM–12:00 PM CDT

Abstract Title: Phase 2 study of adjuvant botensilimab in combination with balstilimab in patients with microsatellite-stable colorectal cancer and persistent circulating tumor DNA following surgery and chemotherapy
Abstract No.: TPS3689
Presenter: Neil Segal, MD; Memorial Sloan Kettering Cancer Center
Session Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal
Location: Hall A – Posters and Exhibits
Poster Board: 447b
Date/Time: May 30, 2026, 9:00 AM–12:00 PM CDT

(Press release, Agenus, APR 21, 2026, View Source [SID1234664628])

On April 21, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported that clinical imaging and dosimetry data of AKY-2519 in patients with various B7-H3 expressing solid tumors will be presented in two poster presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29 – June 2, 2026, in Chicago.

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AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumors, including prostate and lung cancers. In March 2026, the U.S. Food and Drug Administration (FDA) cleared Investigational New Drug (IND) applications for Aktis to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is the second clinical-stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical trial. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors.

Details of the ASCO (Free ASCO Whitepaper) presentations on AKY-2519 are as follows:

Presentation Title: AKY-2519, a novel B7-H3–targeted radioconjugate, and its biodistribution profile in patients with mCRPC*
Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster #: 234
Abstract #: 3097
*This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging and normal tissues and tumor dosimetry analyses through sequential SPECT/CT imaging of patients with mCRPC was conducted at the Nuclear Medicine Research Infrastructure (NuMeRI), University of Pretoria and Steve Biko Academic Hospital, South Africa.

Presentation Title: First-in-human PET/CT imaging with 68Ga-AKY-2519, a B7-H3 targeted miniprotein radioconjugate, to demonstrate tumor uptake and normal tissue exposure across various advanced solid tumors**
Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster #: 235
Abstract #: 3098
**This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging in various solid tumors was conducted at the Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK), Universitätsklinikum Essen (University Hospital Essen), Essen, Germany.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, APR 21, 2026, View Source [SID1234664626])

On April 21, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported updated clinical data from two Phase 1/2 trials of daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). Data from the daraxonrasib combination cohort will be presented in a late-breaking mini-symposium, and data from the monotherapy cohort will be presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 21, 2026.

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Findings from both trials support daraxonrasib’s continued evaluation in the first line setting, demonstrating manageable safety and tolerability profiles along with early signs of durable antitumor activity across monotherapy and combination approaches.

"Patients with metastatic pancreatic cancer continue to face challenging outcomes," said Eileen M. O’Reilly, M.D., Winthrop Rockefeller Endowed Chair of Medical Oncology at Memorial Sloan Kettering Cancer Center, and a key investigator for the RMC-6236-001 trial. "What I find notable about these datasets is the strength of antitumor activity observed with daraxonrasib across both monotherapy and combination therapy, along with manageable safety profiles. With longer follow up, these results further support the potential of a novel RAS-targeted therapy to meaningfully improve outcomes in frontline metastatic PDAC."

"The activity observed with daraxonrasib in the first line setting, as both single-agent and combination therapy, represents a promising signal in this difficult-to-treat population," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "We believe these findings support continued evaluation of daraxonrasib in the ongoing Phase 3 RASolute 303 trial in patients with previously untreated metastatic PDAC."

Daraxonrasib plus Chemotherapy as First Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma (Abstract #LB407)

RMC-GI-102 (NCT06445062) is a Phase 1/2 open-label, multicenter trial with multiple cohorts evaluating daraxonrasib-based combinations in patients with RAS mutant gastrointestinal tumors. The results to be presented at the AACR (Free AACR Whitepaper) Annual Meeting focus on patients in the first line metastatic PDAC cohort treated with daraxonrasib plus gemcitabine and nab-paclitaxel (GnP).

As of a December 1, 2025 data cutoff, 40 patients with previously untreated RAS mutant metastatic PDAC received daraxonrasib 200 mg once daily in 28-day cycles plus GnP given on a Day 1 and Day 15 schedule. In these patients, daraxonrasib plus GnP had a manageable safety profile, and the safety profile observed for the combination regimen was consistent with the known safety findings of each respective agent. The most common Grade ≥3 treatment-related adverse events (TRAEs) were anemia (33%), decreased neutrophil count (20%), and fatigue (18%). No Grade 5 TRAEs were reported. In the trial, TRAEs led to discontinuation of daraxonrasib in 5% (n=2) of patients and of GnP in 15% (n=6) of patients. The mean dose intensity was 82% for daraxonrasib and 80% for GnP.

Daraxonrasib plus GnP showed encouraging preliminary antitumor activity in patients with previously untreated RAS mutant metastatic PDAC. In patients who had at least 18 weeks of follow up prior to the data cutoff (n=40), the confirmed objective response rate (ORR) was 58% (95% confidence interval (CI): 41, 73), including one complete response. Median progression-free survival (PFS) and median overall survival (OS) were not mature at the data cutoff. The Kaplan-Meier estimate for PFS at 6 months was 84% (95% CI: 68, 93) and for OS was 90% (95% CI: 76, 96).

Daraxonrasib Monotherapy as First Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma (Abstract #LB337)

RMC-6236-001 (NCT05379985) is a Phase 1/2 open-label, multicenter trial evaluating daraxonrasib monotherapy in patients with RAS mutant solid tumors.

As of a December 1, 2025 data cutoff, patients with previously untreated RAS mutant metastatic PDAC received daraxonrasib 300 mg daily in 21-day cycles. In these patients, the safety profile observed for daraxonrasib was generally consistent with the reported safety findings for daraxonrasib monotherapy in previously treated patients. All-grade TRAEs occurred in 95% (n=38) of patients and Grade ≥3 TRAEs occurred in 38% (n=15) of patients. The most common Grade ≥3 TRAEs reported in at least 10% of patients were rash, diarrhea, and stomatitis. No Grade 4 or 5 TRAEs were reported. The mean dose intensity was 84%.

Daraxonrasib demonstrated encouraging preliminary antitumor activity in patients with previously untreated RAS mutant metastatic PDAC, with an ORR of 47% (95% CI: 31, 64), including one complete response, and a disease control rate of 92% (95% CI: 79, 98). Median PFS and median OS data were not yet mature at the data cutoff. The Kaplan-Meier estimate for PFS at 6 months was 71% (95% CI: 53, 83) and for OS was 83% (95% CI: 67, 92).

Daraxonrasib is being evaluated in four global Phase 3 clinical trials: three in PDAC (two ongoing and one completed) and one in non-small cell lung cancer (NSCLC). The company recently announced that the pivotal Phase 3 RASolute 302 clinical trial in patients with previously treated metastatic pancreatic cancer met all primary and key secondary endpoints, including PFS and OS. In the trial, daraxonrasib demonstrated an unprecedented OS benefit in all enrolled patients (the intent to treat population), including those with tumors with and without (wild type) an identified RAS mutation.

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%.3,4

About Daraxonrasib

Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a broad range of cancers driven by oncogenic RAS, including PDAC, NSCLC and colorectal cancer. Daraxonrasib suppresses RAS signaling by blocking the interaction of wild-type and mutant RAS(ON) with its downstream effectors.

(Press release, Revolution Medicines, APR 21, 2026, View Source [SID1234664621])

On April 21, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported preclinical data highlighting an innovative new class of mutant-targeted catalytic RAS(ON) inhibitors. These catalytic inhibitors are designed to promote the conversion of mutant RAS in its active RAS(ON) state back to the inactive RAS(OFF) state thereby mimicking the physiological regulation of wild type RAS. This mechanism represents a differentiated approach to inhibition of oncogenic RAS signaling with the goal of addressing tumor resistance mechanisms and extending the durability of current RAS-targeted therapies.

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Results will be presented during a mini symposium at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 21, 2026 (Abstract #6782).

"Additional strategies are needed to counter emergent resistance to RAS inhibitors and further extend clinical benefit for patients with RAS mutant cancers," said Jan Smith, Ph.D., chief scientific officer, Revolution Medicines. "Using our cyclophilin A tri-complex platform, we have discovered a new class of mutant-targeted RAS(ON) catalytic inhibitors designed to stimulate the GTPase activity of mutant RAS variants, a long-sought goal of the RAS research community. In preclinical models, RM-055, an oral compound with this mechanism as the primary driver of RAS pathway inhibition, drove deep and durable tumor regressions across multiple tumor types and overcame resistance to prior RAS inhibition."

At well-tolerated doses, RM-055 demonstrated robust and durable antitumor activity across KRAS G12 mutant xenograft models of pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer. Notably, tumors that had escaped prior RAS inhibitor treatment were sensitive to RM-055, which drove deep and durable regressions warranting further investigation of its potential to counter emergent drug resistance and extend clinical benefit.

Mutant RAS variants causing cancer are relatively insensitive to the natural GTPase-activating proteins (GAPs) that induce physiological inactivation of wild type RAS by stimulating hydrolysis of RAS-GTP to RAS-GDP. Similar to the natural GAPs, RM-055 accelerates the hydrolysis of mutant RAS-GTP to RAS-GDP, converting oncogenic RAS from its active RAS(ON) state to an inactive RAS(OFF) state. A single cyclophilin A:RM-055 binary complex can inactivate multiple mutant RAS proteins.

In preclinical studies, RM-055 significantly reduced RAS-GTP levels in cells, leading to inhibition of downstream RAS signaling and tumor cell proliferation. In vivo RM-055 preferentially suppressed RAS pathway activation in KRAS G12 mutant tumors over normal tissues. This mutant-targeted activity, with a reduced impact on wild-type RAS in normal tissues, suggests the potential for an enhanced therapeutic window and increased flexibility for combination approaches. Moreover, this approach may enable durable pathway suppression even in tumors with increased RAS signaling, a common mechanism of clinical acquired resistance to RAS inhibition.

This novel class of catalytic inhibitors complements Revolution Medicines’ broad portfolio of RAS(ON) multi- and mutant-selective inhibitors that act primarily through steric inhibition of RAS(ON) and further highlights the potential of the cyclophilin A tri-complex platform to enable chemical mechanisms that have not been achieved previously with conventional small molecule strategies.

(Press release, Revolution Medicines, APR 21, 2026, View Source [SID1234664620])

On April 21, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that detailed results from the global, randomized Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) will be presented in a Plenary Session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026 in Chicago.

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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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Revolution Medicines recently reported an unprecedented overall survival (OS) benefit with daraxonrasib from the RASolute 302 clinical trial. These topline results showed that daraxonrasib taken once daily orally met all primary and key secondary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and OS compared with standard of care intravenous cytotoxic chemotherapy. The presentation will describe these findings, as well as additional analyses of efficacy and safety.

Presentation Details

Presenting Author: Brian M. Wolpin, M.D., M.P.H., Dana-Farber Cancer Institute
Title: Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Primary and final analysis from the phase 3 RASolute 302 study
Abstract: LBA5
Session Name: Plenary Session
Session Date: May 31, 2026
Presentation Time: 3:21-3:33 PM CDT
Location: McCormick Place, Hall B1

Additional Accepted Abstracts

The following additional Revolution Medicines–sponsored abstracts have been accepted for online publication:

Systemic anticancer therapy in patients with de novo metastatic pancreatic adenocarcinoma: a real-world analysis (Abstract #e16383)
Patient characteristics, treatment patterns, and survival in a metastatic pancreatic adenocarcinoma U.S. patient population (Abstract #e16379)
Safety and efficacy of daraxonrasib monotherapy as later-line (3L+) treatment for patients (pts) with metastatic pancreatic adenocarcinoma (PDAC) (Abstract #e15104)

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 standard of care cytotoxic chemotherapy. 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 RASolute 302 are progression-free survival (PFS), as assessed by a Blinded Independent Central Review, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints include 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 mutations, 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, APR 21, 2026, View Source [SID1234664619])