On May 31, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) (Eikon), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported presentations on several of its lead programs at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, including updated data for its EIK1001 trial in non-small cell lung cancer (NSCLC) and its highly selective PARP1 inhibitor EIK1003.

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"We are pleased to present six abstracts at ASCO (Free ASCO Whitepaper) reflecting both the progress of our pipeline and the growing body of evidence supporting our lead programs," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon. "In our most advanced program, EIK1001 demonstrated encouraging response rates and durability in combination with standard of care in first-line NSCLC. We also observed meaningful clinical activity of EIK1003 both as a monotherapy and, potentially a first for the field, in combination with paclitaxel, including responses in heavily pretreated patients. Together, these data continue to reinforce the scientific rationale behind our programs and their potential to deliver meaningful benefit to people living with cancer."

EIK1001 Clinical Update.

Updated data from our ongoing Phase 2 trial evaluating the safety and tolerability of EIK1001 in combination with both pembrolizumab and histology appropriate chemotherapy for the front-line treatment of patients with advanced NSCLC, also known as our TeLuRide-005 trial, provide evidence of a potentially durable effect of EIK1001 in combination with standard of care, and a preliminary tolerability profile supportive of systemic administration in an out-patient setting, a potential key differentiator of EIK1001 from previous TLR7/8 targeted therapies.

EIK1001 is an investigational, systemically administered dual-agonist of Toll-like receptors 7 and 8 designed to stimulate both innate and adaptive immune responses. In Phase 1 trials of EIK1001, single-agent activity was observed in patients with advanced malignancy. This mechanism may complement the antitumor immune response engendered by PD-(L)1 blockade.

TeLuRide-005 is our multicenter, open-label trial of once-weekly (QW) systemically administered EIK1001 in combination with standard of care, once every third week (Q3W) pembrolizumab and histology appropriate chemotherapy in first-line, treatment-naïve patients with stage 4 NSCLC. Enrollment completed in the first quarter of 2026.

As of enrollment cutoff, 72 participants with previously untreated stage 4 NSCLC received intravenous EIK1001 QW combined with standard of care pembrolizumab plus chemotherapy Q3W. After 8 cycles, EIK1001 administration was reduced to Q3W. The maximum treatment duration is 2 years (up to 35 cycles) for EIK1001 in combination with pembrolizumab, with pemetrexed continued at the discretion of the Investigator for non-squamous patients.

At the March 17, 2026 safety data cutoff, among the safety evaluable population (n=72: 39 non-squamous; 33 squamous), the combination of EIK1001 with pembrolizumab and chemotherapy was generally well tolerated, with an adverse event (AE) profile similar to standard of care alone. Most treatment-emergent adverse events (TEAEs) were Grade 1-2, and the most common Grade 3 or higher treatment-related adverse events (TRAEs) were neutropenia (30.6%), anemia (9.7%), and thrombocytopenia (9.7%). All cytokine release syndrome (CRS) AEs were Grade 1 and 2, and all CRS events occurred before Cycle 4 in all but one patient. This profile was sufficient to support administration in an out-patient setting during the ongoing trial.

Among the efficacy-evaluable population (n=65: 36 non-squamous; 29 squamous), EIK1001 treatment in combination with pembrolizumab and chemotherapy resulted in a 63.1% objective response rate (ORR) and 90.8% disease control rate (DCR) at the efficacy data cutoff of May 4, 2026. Among participants in the non-squamous cohort, an ORR of 55.6% and a DCR of 83.3% were observed, respectively, with a median follow-up of 13.6 months. The median duration of response (DOR) in the non-squamous cohort was greater than 11 months at the efficacy data cutoff. Among participants in the squamous cohort, for which the data set was still maturing at the data cutoff due to slower enrollment, an ORR of 72.4% and a DCR of 100% were observed, respectively, with a median follow-up of 8.8 months.

EIK1003 Clinical Update.

Updated data from EIK1003-001, our Phase 1/2 trial evaluating the safety and efficacy of EIK1003 as monotherapy or in combination with anti-cancer agents in participants with advanced solid tumors, demonstrate that EIK1003 monotherapy (Cohort 1A) was generally well-tolerated across multiple dose levels. In Cohort 1C, signals of antitumor activity were observed with EIK1003 in combination with weekly paclitaxel, with a combination safety profile consistent with paclitaxel’s known toxicities. These data support what appears to be a unique profile for EIK1003 in combination strategies within the evolving PARP inhibitor landscape.

EIK1003 is an investigational, highly-selective PARP1 inhibitor designed to leave PARP2 signaling intact. PARP2 inhibition may be a key driver of the hematological toxicity associated with first generation, non-selective PARP inhibitors.

Cohort 1A: Updated EIK1003 Monotherapy Data

As of the enrollment cutoff, 65 patients with breast, ovarian, prostate, or pancreatic cancer have been treated in Cohort 1A with EIK1003 monotherapy at doses ranging from 10mg to 160mg once daily (QD), using a Bayesian optimal interval dose-escalation design to assess for safety, tolerability, pharmacokinetics and antitumor activity. This represents an expansion of the dataset previously presented at ASCO (Free ASCO Whitepaper) 2025, with additional patients enrolled and longer follow-up.

At the February 27, 2026 safety data cutoff, the updated safety profile in Cohort 1A remained generally consistent with data previously presented at ASCO (Free ASCO Whitepaper) 2025. Treatment-emergent adverse events (TEAEs) were reported in 63 of 65 patients (96.9%). Grade 3 or higher TEAEs occurred in 29 patients (44.6%); the most common were anemia (9.2%), neutropenia (7.7%), and ascites (7.7%). 4 of the 6 patients who developed Grade 3 or higher anemia had Grade 1-2 anemia at study entry. TEAEs led to dose reductions in 7 patients (10.8%) and to treatment discontinuation in 6 patients (9.2%). No TRAEs leading to death were reported.

Among efficacy-evaluable patients in Cohort 1A (n=49), ORR was 14.3% overall and 26.7% in PARP-naïve patients. Objective responses by tumor type were 14.8% (4/27) in ovarian cancer, 12.5% (2/16) in breast cancer, and one patient with prostate cancer. Median duration of response among confirmed responders (n=5) was 7.8 months at the efficacy data cutoff of May 4, 2026.

Cohort 1C: Initial Data on EIK1003 in Combination with Weekly Paclitaxel

As of the February 27, 2026 safety data cutoff, 60 patients with platinum-resistant ovarian cancer or HER2-negative breast cancer that failed chemotherapy or hormonal therapy have been treated in Cohort 1C with EIK1003 at doses ranging from 10mg to 60mg QD in combination with paclitaxel 80 mg/m2 IV QW. Dose-limiting toxicities of febrile neutropenia and tachycardia were reported in one patient each at the highest dose level tested, 60mg. TEAEs were reported in 60 out of 60 patients (100%). Grade 3 or higher TEAEs occurred in 45 patients (75%); the most common were neutropenia (50%) and anemia (13.3%). Neutropenia is a known and expected adverse event associated with weekly paclitaxel chemotherapy. All 8 patients who developed Grade 3 or higher anemia had Grade 1-2 anemia at study entry. TEAEs led to dose reductions in 15 patients (25%) and discontinuation of one or both study drugs in 11 patients (18.3%). No TRAEs leading to death were reported.

Among efficacy-evaluable patients in Cohort 1C (n=53), ORR was 24.5%; 12 of 13 responders (92%) had received prior taxane therapy. Objective responses by tumor type were 29.6% (8/27) in platinum-resistant ovarian cancer and 19.2% (5/26) in breast cancer. Duration of response among confirmed responders (n=9) ranged from 1.5 to 11.4 months, with responses ongoing in 3 responders at the efficacy data cutoff of May 4, 2026.

2026 ASCO (Free ASCO Whitepaper) Abstract Titles.

EIK1001

Title: Efficacy, safety and cytokine profiling with addition of the toll-like receptor (TLR) 7/8 dual agonist EIK1001 to Standard of Care First-Line Therapy: the Phase 2 TeLuRide-005 trial in Stage 4 Non-Small Cell Lung Cancer

Title: Adaptive Phase 2/3 Study of EIK1001, a TLR7/8 Dual Agonist, in Combination with Pembrolizumab, as First-Line Therapy in Participants with Advanced Melanoma (TeLuRide-006)

Title: A Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008)

EIK1003

Title: EIK1003, a PARP1-selective inhibitor, in combination with paclitaxel (PTX): Initial combination and updated monotherapy results from a Phase 1/2 study EIK1003-001 in advanced solid tumors

EIK1005

Title: First-in-Human Study to Evaluate the Safety, Tolerability, and PK of EIK1005, a Novel WRN Inhibitor in Healthy Participants

Title: Phase 1/2 Study of the novel Werner helicase inhibitor EIK1005 as Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors, including MSI-H or dMMR Tumors (Publication only)

Copies of the 2026 ASCO (Free ASCO Whitepaper) presentations will be made available on our website: www.eikontx.com under Scientific Papers & Publications.

(Press release, Eikon Therapeutics, MAY 31, 2026, View Source [SID1234666287])

On May 31, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that positive performance and safety results from the analysis of the full 35,878 cohort of its registrational PATHFINDER 2 study are being presented during an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The PATHFINDER 2 study evaluated the safety and performance of the Galleri multi-cancer early detection (MCED) test when used alongside standard-of-care cancer screenings in the U.S. and Canada. The prospective PATHFINDER 2 study is the largest interventional study of an MCED in North America to date and includes 35,878 participants in a broad, intended-use population of adults aged 50 and older with no clinical suspicion of cancer.

"Cancer outcomes depend not only on better treatments, but on finding cancer before it advances and spreads. Earlier detection can open the door to more treatment options at any stage and increase the chance for cure," said Josh Ofman, MD, MSHS, President and CEO-Elect at GRAIL. "These PATHFINDER 2 results add to the growing body of clinical evidence in a large, representative intended-use population showing that the Galleri test can meaningfully increase cancer detection beyond recommended screening with strong performance and a highly favorable safety profile. Along with the NHS-Galleri trial results, these findings reinforce the clinical benefit of Galleri and its potential to transform early cancer detection at population scale."

Galleri Increases the Number of Cancers Detected and Can Detect Them Early

While effective screening improves early cancer detection, in the U.S., only 14% of all cancers are detected by guideline-recommended screening tests[2]. In PATHFINDER 2, 60% of diagnosed cancers were screen-detected (264/440). Adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a 6.5 fold increase in the number of cancers found by screening. Galleri detected nearly three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations).

More than half (53.0%) of the new cancers detected by Galleri were stage I or II, and 71.3% of these have no USPSTF A and B recommended screening. More than two-thirds (70.9%) of the new cancers detected by Galleri were detected at stages I-III, when treatment with curative intent is more often possible.

"PATHFINDER 2 provides important additional data on the performance and safety of MCED testing," said Karthik Giridhar, M.D., assistant professor of oncology at Mayo Clinic and a principal investigator on the PATHFINDER 2 study. "MCED tests are not a replacement for existing screening, but they have the potential to complement current approaches by helping detect cancer signals across multiple cancer types, including some for which routine screening is not currently available."

Robust Performance Metrics Consistent with Previous Studies

The Galleri test detected a cancer signal in 287 participants, and of those, cancer was diagnosed in 173 participants. The likelihood of receiving a cancer diagnosis following a positive test result (positive predictive value or PPV) was 60.3%, consistent with previously reported initial results of PATHFINDER 2 and higher than the first PATHFINDER study.

Since PATHFINDER 2 is a prospective clinical trial where the cancer status of participants is unknown at the outset, episode sensitivity – the ability to detect cancer that could be confirmed within 12 months after the blood draw – is evaluated in the study. Galleri demonstrated strong performance, with 69.8% episode sensitivity for the 12 cancers responsible for two-thirds of cancer deaths in the U.S. For all cancers, episode sensitivity was 39.3%.

Specificity was 99.6%, translating to a false positive rate of less than 0.4%.

"The up to 6.5 fold improvement in screen-detected cancers with Galleri in PATHFINDER 2 study, coupled with the greater than 20% reduction in Stage 4 cancers observed in the NHS-Galleri trial, is really exciting data that help support Galleri’s performance in a diverse and representative population," said Nima Nabavizadeh, MD, Associate Professor of Radiation Medicine at Oregon Health & Science University. "As an oncologist, I have seen too many patients diagnosed only after their cancer has spread, when treatment decisions become more difficult. By helping find more cancers earlier, when more treatment options may be available, there is great potential for multi-cancer early detection to transform cancer screening."

Galleri Pinpoints Cancer Signal Origin Allowing Efficient Diagnostic Workups

A key benefit of the Galleri test is its ability to predict where in the body the cancer signal is coming from. The PATHFINDER 2 study demonstrated that the test correctly identified the Cancer Signal Origin (CSO) 91.3% of the time, leading to efficient diagnostic workups. Diagnostic resolution took a median of 48 days, and only 0.6% of all safety-analyzable participants had an invasive procedure (213/35,335) following a positive MCED test result. A total of 90.5% of invasive procedures were nonsurgical.

Screening with the Galleri test had a favorable safety profile, with a low false-positive rate and a low rate of invasive procedures. There were five study-related adverse events reported during diagnostic evaluation, only in those with cancer diagnosis. Anxiety temporarily increased for participants with a positive MCED test and subsequent cancer diagnosis, and returned to baseline by 12 months, as has been observed for other screening tests. One serious adverse event related to the diagnostic work-up was identified after the data lock. Follow-up is ongoing; this and any other findings after data lock will be reported in full in the next interim analysis.

About PATHFINDER 2 (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and performance of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), episode sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes over several time points, including an assessment of participants’ anxiety and satisfaction with the MCED test.

(Press release, Grail, MAY 31, 2026, View Source [SID1234666272])

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 30, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Bristol Myers Squibb Company (NYSE: BMY, "BMS") reported interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) evaluating the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig (also known as BNT327 or BMS-986545) plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer ("NSCLC").

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The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level (TPS ˂ 1%, TPS 1 – 49%, and TPS ≥ 50%). The data are being presented today as a rapid oral presentation (abstract #8513) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago.

"Despite significant immuno-oncology advances in the treatment of non-small cell lung cancer, most advanced diseases relapse on or after a PD-(L)1 checkpoint inhibitor treatment,1 indicating that targeting this immunologic pathway alone is insufficient to achieve durable responses," said Solange Peters, M.D., Ph.D., Lead Investigator and Director of Oncology at the University Hospital of Lausanne, Switzerland. "I am encouraged by the efficacy signal with this bispecific approach, showing robust responses across subtypes and PD-L1 levels, supporting the continued investigation of pumitamig and its potential to deliver improved outcomes for a broad range of patients with NSCLC."

The Phase 2 part of the ROSETTA Lung-02 trial evaluated pumitamig in two dose levels, in combination with chemotherapy. At this interim analysis at the April 13, 2026 data cut-off, among 40 response-evaluable patients with a median follow-up of 9.0 months, pumitamig plus chemotherapy showed a confirmed objective response rate ("cORR") of 57.1% in patients with non-squamous NSCLC and 68.4% with squamous NSCLC with a disease control rate ("DCR") of 100%. Encouraging anti-tumor activity was observed at both dose levels, with higher response rates at the lower dose showing a cORR of 63.6% for non-squamous and 72.7% for squamous NSCLC. Results were high at each PD-L1 expression level (cORR: 47.6% TPS ˂ 1%; 77.8% TPS 1 – 49 %; 100% TPS ≥ 50%).

Pumitamig plus chemotherapy demonstrated a manageable safety profile with a low discontinuation rate. Grade ≥ 3 treatment-related adverse events ("TRAEs") were reported in 48.8% of patients and were considered pumitamig-related in 23.3%, leading to treatment discontinuation in four (9.3%) patients. Immune-related AEs ("irAEs") occurred in 16 (37.2%) patients and grade ≥ 3 irAEs in two (4.7%) patients. Bleeding events were reported in nine (20.9%) patients, with only one event being grade 3.

"The data we are presenting today provide further evidence of the potential of pumitamig to enhance anti-tumor responses in advanced lung cancer, one of the most challenging indications, by simultaneously targeting PD-L1 and VEGF-A with a single molecule," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Pumitamig has consistently shown efficacy in three global Phase 2 trials across PD-L1 expression levels. Together with our partner BMS, we are continuing to advance pumitamig in ongoing pivotal and novel-novel combination trials with the goal of delivering better outcomes for more patients."

"We are committed to advancing the science of lung cancer with pumitamig and improving on the standard of care for people with this challenging disease," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb. "With one of the broadest registrational programs in the class, we are focused on accelerating the development of pumitamig together with BioNTech, with the goal of delivering meaningful benefit to patients, including those who have been left behind by current therapies."

BioNTech and BMS are advancing a broad development plan for pumitamig in non-small cell lung cancer across disease stages and subgroups. In addition to the ongoing global ROSETTA Lung-02 trial, which is currently recruiting for the Phase 3 part of the trial, there are two additional global Phase 3 clinical trials in NSCLC currently enrolling. These include ROSETTA Lung-201 (NCT07361497), evaluating pumitamig compared to durvalumab following concurrent chemoradiation therapy in patients with unresectable stage III NSCLC; and ROSETTA Lung-202 (NCT07361510), evaluating pumitamig compared to pembrolizumab as a first-line treatment for patients with advanced PD-L1 ≥ 50% NSCLC. Pumitamig is also being investigated in combination with other novel investigative treatments for NSCLC, including in combination with investigational antibody-drug conjugates ("ADCs") and other modalities.

About ROSETTA Lung-02
The global Phase 2/3 ROSETTA Lung-02 trial (NCT06712316) is evaluating pumitamig (BNT327/ BMS986545) in combination with chemotherapy in patients with first-line treatment of non-squamous and squamous non-small cell lung cancer without actionable genomic alterations and with any level of PD-L1 expression. In the Phase 2 dose-optimization part of the trial, patients were randomized 1:1 to 1400 mg or 2000 mg pumitamig plus histology-specific chemotherapy Q3W (non-squamous: carboplatin + pemetrexed; squamous: carboplatin + paclitaxel). The primary endpoints of the Phase 2 part of the trial are objective response rate (ORR) per investigator’s assessment (RECIST 1.1), best percentage change in tumor size from baseline, and safety. Key secondary endpoints include duration of response (DOR) and disease control rate (DCR). The Phase 3 part of the trial will evaluate pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Based on the totality of the data, a pumitamig 1500 mg flat dose Q3W plus chemotherapy was selected for further evaluation in the Phase 3 part. The primary endpoint of the Phase 3 part of the trial is progression free survival (PFS) assessed by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS), ORR, DOR.

About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 2,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA LUNG-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA LUNG-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA BREAST-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA GASTRIC-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.2 Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.3 Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.

(Press release, BioNTech, MAY 30, 2026, View Source [SID1234666242])

On May 30, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported detailed clinical data from the primary analysis of the PEAK Phase 3 trial of bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib.

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The presentation titled Primary Results of the Phase 3 Peak Study of Bezuclastinib + Sunitinib vs Sunitinib Monotherapy in Advanced Gastrointestinal Stromal Tumors (GIST) ​will be presented by Andrew Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and will be available on the Cogent website at View Source

"We are thrilled with the results from the PEAK Phase 3 trial demonstrating a statistically significant and clinically meaningful improvement in progression-free survival and objective response rate with bezuclastinib in combination with sunitinib compared to sunitinib alone," said Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences. "Importantly, there was a clear benefit across all mutational patient subgroups, coupled with a safety profile generally consistent with the known profile of single agent sunitinib. Building on our announcement that the bezuclastinib combination was granted FDA Priority Review earlier this week, we plan to launch bezuclastinib later this year and are well prepared to ensure bezuclastinib combination access for GIST patients in need."

"The results presented today clearly demonstrate that the combination of bezuclastinib and sunitinib provides impressive clinical activity for patients with KIT-driven gastrointestinal stromal tumors," said Andrew Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. "I am very excited about the potential for this combination and expect it will be rapidly adopted as the new standard of care for patients with second-line GIST."

PEAK Phase 3 Trial Results

As reported in November 2025, PEAK is a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST. As of the cutoff date, September 30, 2025, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of PFS, reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. Data for overall survival remains immature.

Based on the ongoing patients receiving treatment on the bezuclastinib arm as of March 31, 2026, the mean duration of treatment for the bezuclastinib combination is now estimated to be 21.4 months.

Results of Genotype Subgroup Analysis

Using all genotyping information available at baseline, a comparative analysis of PFS was performed across several patient subgroups based on their primary and secondary KIT mutation status. Across all subgroups, the bezuclastinib combination demonstrated a clear advantage over sunitinib monotherapy.

Cogent_Genotype Subgroup

PFS2 Results

Additional data presented today demonstrate impressive benefit for patients receiving the bezuclastinib combination when measuring PFS2, defined as the time from randomization to progression on the next line of therapy or death. Median PFS2 was not reached versus 21 months (HR=0.57, 95% CI: 0.41-0.78) for patients initially treated with the bezuclastinib combination compared with sunitinib monotherapy. This finding reinforces the durability of clinical benefit for patients receiving the bezuclastinib combination.

Safety Data

As of the data cutoff, the bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. The most commonly reported Grade 3+ treatment emergent adverse events in either arm (bezuclastinib combination vs. sunitinib) included: Hypertension (29.4% vs. 27.4%), Neutropenia (15.2% vs. 15.4%), ALT/AST increased (10.8% vs. 1.4%), Anemia (9.3% vs. 4.8%) and Diarrhea (7.8% vs. 7.2%). 7.4% of patients on the bezuclastinib combination and 3.8% of patients on sunitinib monotherapy discontinued study treatment(s) due to treatment related adverse events. Hepatic adverse events were predominantly transient and manageable lab abnormalities; the majority of which were asymptomatic, low grade, non-serious and reversible. In the combination arm, ALT/AST elevations led to bezuclastinib dose reductions in 12.7% of patients with only 3 subjects (1.5%) discontinuing bezuclastinib for ALT/AST elevations. All Grade 3 ALT/AST elevations resolved, and no Grade 4 elevations were reported.

Bezuclastinib Combination in Exon 9 First Line GIST Patients

Cogent also announced today the initiation of a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of the bezuclastinib combination in first-line GIST patients with KIT exon 9 primary mutations who have received limited or no imatinib treatment. This cohort is designed to prospectively measure ORR and PFS in this patient population, building upon the 25.1 mPFS reported in a subgroup of 32 patients with detectable exon 9 mutations treated with the bezuclastinib combination in the Phase 3 PEAK trial.

Bezuclastinib – Expanded Access Program

Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. For more information please visit: View Source

(Press release, Cogent Biosciences, MAY 30, 2026, View Source [SID1234666243])