On May 31, 2026 Hanmi Pharm. Co., Ltd. ("Hanmi") reported that they have entered into a license agreement for the development, manufacturing and commercialization of Hanmi’s biologic drug candidate sonefpeglutide (LAPSGLP-2 analog) with Eli Lilly and Company ("Lilly").

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Sonefpeglutide is a novel drug candidate incorporating Hanmi’s proprietary long-acting platform technology, LAPSCOVERY. Hanmi has previously received FDA marketing approval for a biologic incorporating its LAPSCOVERY platform and is currently conducting additional global clinical trials for five other programs utilizing the same platform.

Hanmi has focused on the biological functions of glucagon-like peptide 2 (GLP-2) – including the promotion of intestinal growth, reduction of inflammation, and protection and regeneration of the intestinal mucosa – and has demonstrated these effects through a range of non-clinical studies. The company has also presented the therapeutic potential of LAPSGLP-2 across multiple indications at major scientific conferences. Hanmi is currently conducting a global Phase 2 clinical trial in short bowel syndrome (SBS).

Hanmi will continue to conduct the ongoing global Phase 2 trial in SBS through completion while Lilly will explore additional clinical trials for sonefpeglutide based on its nonclinical and clinical data.

Through this agreement, Lilly will obtain exclusive rights to develop, manufacture and commercialize sonefpeglutide worldwide, excluding Korea.

Juhyun Lim, Vice Chairman of Hanmi, stated, "It is highly meaningful that Lilly—one of the most closely watched innovators globally—has highly recognized the development potential for sonefpeglutide." She added, "Hanmi will continue to advance innovative drug development, guided by our mission of ‘Respect for People and Value Creation.’"

Under the agreement, Hanmi will receive an upfront payment of USD 75 million and may receive up to an additional USD 1.185 billion in clinical development, regulatory approval and commercialization milestone payments. In addition, Hanmi will be eligible to receive royalties following product launch.

(Press release, Hanmi, MAY 31, 2026, View Source [SID1234666261])

On May 31, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported positive overall survival (OS) results from the Phase III HARMONi-6 trial, conducted in China and sponsored by Summit’s partner Akeso, Inc. (HKEX Code: 9926.HK), will be presented today as part of the Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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The presentation is entitled "Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in previously untreated advanced squamous non-small cell lung cancer: Overall survival results of the phase 3 HARMONi-6 trial." HARMONi-6 is evaluating ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression. HARMONi-6 is a single region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. The trial’s primary endpoint is progression-free survival (PFS), and OS is a key secondary endpoint.

The trial results will be presented by Dr. Shun Lu, MD, PhD, Chief of Shanghai Lung Cancer Center at Shanghai Chest Hospital, Professor of Medicine at Shanghai Jiaotong University, and associate editor for the Journal of Thoracic Oncology.

In major markets globally, first-line therapy for patients with advanced NSCLC without driver mutations is most commonly a PD-1 inhibitor plus platinum-based chemotherapy. Prior to HARMONi-6, there were no known Phase III clinical trials in advanced NSCLC which have shown a statistically significant and clinically meaningful improvement in OS when compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting. Examples of PD-(L)1 inhibitors include pembrolizumab, nivolumab, tislelizumab, and atezolizumab.

Clinically Meaningful Efficacy

In the HARMONi-6 planned interim analysis of OS, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement when compared to tislelizumab in combination with chemotherapy, with a hazard ratio (HR) of 0.66 (95% CI: 0.50, 0.87; p=0.0017). A clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression. OS rates at 24 months were 64.7% for those patients receiving ivonescimab plus chemotherapy compared to 48.6% for those receiving tislelizumab plus chemotherapy. Median follow-up time of the current data cut was 21.4 months.

HARMONi-6 ITT (n=532):

Median Follow-up: 21.36 mos.

Ivonescimab + Chemo

(n=266)

Tislelizumab + Chemo

(n=266)

Median OS

27.89 mos.

(95% CI: 27.89, NE)

23.69 mos.

(95% CI: 20.11, NE)

24-Month OS Rates

64.7%

48.6%

OS Stratified HR

0.66

(95% CI: 0.50, 0.87; p= 0.0017)

mos.: months; NE: not established

HARMONi-6 PD-L1 Subgroup Analyses

Ivonescimab + Chemo vs. Tislelizumab + Chemo

PD-L1 Negative (PD-L1 TPS <1%) OS stratified HR

Ivonescimab + Chemo n=105; Tislelizumab + Chemo n=105

0.64

(95% CI: 0.43, 0.96)

PD-L1 Positive (PD-L1 TPS >1%) OS stratified HR

Ivonescimab + Chemo n=161; Tislelizumab + Chemo n=161

0.68

(95% CI: 0.46, 0.99)

"For the first time, a Phase III clinical study has demonstrated a statistically significant overall survival benefit in front-line driver-mutation-negative non-small cell lung cancer compared to anti-PD-1 therapy in combination with chemotherapy," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. "While this represents another study where ivonescimab has demonstrated a significant OS benefit, these data represent the answer to the question regarding ivonescimab and its ability to translate PFS benefits into the extension of lives for patients with cancer in the front-line setting compared to immunotherapy-based regimens."

The HARMONi-6 study met its primary endpoint as announced in April 2025, showing a statistically significant and clinically meaningful improvement in PFS. Detailed results for efficacy and safety were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress (ESMO 2025) last October and published in The Lancet simultaneously.

Safety Profile

In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous Phase III studies of ivonescimab plus chemotherapy. No additional safety signals were noted in the HARMONi-6 study in this current data cut compared to the previous data cut presented.

Treatment-related serious adverse events occurred in 41.4% of patients receiving ivonescimab in combination with chemotherapy and 34.3% of patients receiving tislelizumab in combination with chemotherapy. Most of the possibly VEGF-related adverse events occurring in the ivonescimab-plus-chemotherapy arm were classified as Grade 1 or 2; Grade 3 or higher hemorrhage events were observed in 2.6% of patients in the ivonescimab-plus-chemotherapy arm compared to 0.8% of patients in the tislelizumab-plus-chemotherapy arm in this study. Treatment-related adverse events (TRAEs) leading to discontinuation in this study occurred in 5.3% of patients receiving ivonescimab plus chemotherapy compared to 4.5% for those receiving tislelizumab plus chemotherapy.

In squamous NSCLC, VEGF-A monoclonal antibodies have had limited clinical development based on historical data demonstrating significant risks of toxicity, including life-threatening hemorrhage and other bleeding complications. The results of this study further validate the unique mechanism of action of ivonescimab, including apparent key differences as compared to historical clinical studies where an anti-PD-1 monoclonal antibody and an anti-VEGF monoclonal antibody were administered separately.

HARMONi-6 Clinical Trial Results Published in The Lancet

The Lancet simultaneously published these findings in a manuscript titled, "Ivonescimab plus Chemotherapy for Squamous Non-small-cell Lung Cancer."

"A heartfelt congratulations to our partner, Akeso, for their continuing, tremendous efforts to make a significant difference in the lives of patients with cancer," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "The decision we made in December 2022 to enter into a partnership specifically with Akeso and accelerate the global clinical development plan of this potentially landscape-changing compound in ivonescimab is further validated with these groundbreaking results for patients facing high unmet medical needs. We look forward to continuing this positive momentum."

Conference Call

Summit will host a conference call and live webcast to discuss recent updates related to ivonescimab, including data released at ASCO (Free ASCO Whitepaper), on Monday, June 1, 2026, at 7:00 a.m. ET. Conference call and webcast information is accessible through the company’s website, www.smmttx.com. An archived edition of the webcast will be available on the website later in the day on Monday.

About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering.

HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in both the HARMONi-A and HARMONi-6 studies, and a manageable safety profile in each study.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

(Press release, Summit Therapeutics, MAY 31, 2026, View Source [SID1234666258])

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])