On May 30, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported results from a subgroup analysis of the phase 3 CABINET pivotal trial, which showed that CABOMETYX (cabozantinib) provided significant improvements in progression-free survival (PFS) versus placebo in patients with previously treated advanced neuroendocrine tumors (NET) regardless of functional status. These data will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held from May 29 – June 2 in Chicago.

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"Understanding the effects of oral pathway inhibitors in patients with both functional and non-functional NET is critical in informing appropriate treatment-sequencing decisions," said Nikolaos A. Trikalinos, M.D., Associate Professor of Medicine, Washington University School of Medicine and Siteman Cancer Center. "Patients with hormone-producing tumors may require approaches that not only control tumor growth but also help mitigate challenging hormone-related symptoms. It is encouraging that our results reinforce cabozantinib as a meaningful treatment option for patients with advanced NET regardless of functional status. In both non-functional and functional NET, cabozantinib delivered substantial improvements in disease control compared to placebo, with median progression-free survival increasing threefold in non-functional NET and more than doubling in functional NET compared to placebo."

In the phase 3 CABINET study, patients with locally advanced or metastatic pancreatic NET (pNET) or extra-pancreatic NET (epNET) were randomized 2:1 in separate cohorts to receive CABOMETYX 60 mg daily versus placebo. Of the 298 patients enrolled in both cohorts, 179 had non-functional NET (cabozantinib, n=123; placebo, n=56), 74 had functional (i.e., hormone-releasing) NET (cabozantinib, n=47; placebo, n=27); and 45 had unknown functional status (cabozantinib, n=28; placebo, n=17).

These subgroup results presented today at ASCO (Free ASCO Whitepaper) 2026 show cabozantinib demonstrated improvements in PFS regardless of functional status. In patients with non-functional NET, the hazard ratio (HR) was 0.26 (95% confidence interval [CI]: 0.17–0.41; p<0.001); median PFS was 9.4 months with cabozantinib (95% CI: 8.5–13.8) versus 3.1 months with placebo (95% CI: 2.9–5.7). In patients with functional NET, the HR was 0.40 (95% CI: 0.20–0.82; p=0.012); median PFS was 12.7 months (95% CI: 8.4–17.9) with cabozantinib versus 5.4 months with placebo (95% CI: 3.7–not estimable).

"Following last year’s U.S. and EU approvals of CABOMETYX for the treatment of previously treated advanced NET, these subgroup findings from the CABINET trial reinforce its ability to delay disease progression for a broad and heterogenous population of these patients," said Dana T. Aftab, Ph.D., Executive Vice President, Research & Development, Exelixis. "CABOMETYX is now the leading oral therapy for previously treated advanced NET, helping to address a significant unmet need for patients who have limited options. We are committed to further improving standards of care for this disease and look forward to learning about the potential of zanzalintinib, our investigational oral kinase inhibitor, to improve outcomes in an early line of treatment compared to everolimus in our ongoing STELLAR-311 pivotal trial."

The safety profile of CABOMETYX observed in patients with functional and non-functional NET was consistent with its known safety profile; no new safety signals were identified. The most frequent grade 3/4 adverse events with cabozantinib in patients with functional NET were hypertension (21%) and diarrhea (9%); in non-functional NET, they were hypertension (21%) and fatigue (18%).

About CABINET (Alliance A021602)

CABINET (Randomized, Double-Blinded, Phase III Study of CABozantinib versus Placebo In Patients with Advanced NEuroendocrine Tumors After Progression on Prior Therapy) is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCI-funded National Clinical Trials Network, as part of Exelixis’ collaboration through a Cooperative Research and Development Agreement with the NCI’s Cancer Therapy Evaluation Program.

CABINET is a multicenter, randomized, double-blinded, placebo-controlled phase 3 pivotal trial that enrolled a total of 298 patients in two separate cohorts (pNET and epNET) in the U.S. at the time of the final analysis. Patients were randomized 2:1 to cabozantinib (60 mg) or placebo; each cohort was randomized separately and had its own statistical analysis plan. The trial was stopped early after an interim analysis showed superior efficacy associated with cabozantinib as compared to placebo in each of the two cohorts. Patients with epNET had primary tumors arising in the GI tract, lung, unknown primary sites and other organs. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression or intolerance after at least one U.S. FDA-approved line of prior systemic therapy other than somatostatin analogs. The primary endpoint in each cohort was PFS per RECIST 1.1 by blinded independent central review. Secondary endpoints included overall survival, objective response rate and safety. More information about this trial is available at ClinicalTrials.gov.

About NET

NET are cancers that begin in the specialized cells of the body’s neuroendocrine system.1 These cells have traits of both hormone-producing endocrine cells and nerve cells.2 It is estimated that 161,000 to 192,000 people in the U.S. are living with unresectable, locally advanced or metastatic NET.2 The number of people diagnosed with NET has been increasing in recent decades.3 Functional NET release peptide hormones that can cause debilitating symptoms, like diarrhea, hypertension and flushing, while symptoms of non-functional NET are related primarily to tumor growth.4,5,6,7,8 Most NET take years to develop and grow slowly, but eventually all patients with advanced or metastatic NET will develop refractory and progressing disease.9,10

NET can start in the pancreas (pNET), where they tend to be more aggressive, with a five-year survival rate of only 19% for advanced disease.2,11 NET can also develop in any part of the body, but most commonly start in the GI tract or in the lungs, where they have historically been referred to as carcinoid tumors and are more recently called epNET.2 The five-year survival rate for advanced GI NET is 68%.12 For advanced NET patients, treatment options include somatostatin analogs, chemotherapy, molecular targeted therapy and peptide-receptor radionuclide therapy.13

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved as monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) and in combination with nivolumab as a first-line treatment for patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible; for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET; and adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET. CABOMETYX tablets have also received regulatory approvals in over 65 countries outside the U.S. and Japan, including the EU. In 2016, Exelixis granted Ipsen Pharma SAS exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: CABOMETYX can cause severe and fatal hemorrhages. The incidence of Grade 3-5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies. Discontinue CABOMETYX for Grade 3-4 hemorrhage and before surgery. Do not administer to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, and gastrointestinal (GI) perforations, including fatal cases, each occurred in 1% of CABOMETYX patients. Monitor for signs and symptoms, and discontinue CABOMETYX in patients with Grade 4 fistulas or GI perforation.

Thromboembolic Events: CABOMETYX can cause arterial or venous thromboembolic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events have occurred. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 37% (16% Grade 3 and <1% Grade 4) of CABOMETYX patients. In CABINET (n=195), hypertension occurred in 65% (26% Grade 3) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled; when controlled, resume at a reduced dose. Permanently discontinue CABOMETYX for severe hypertension that cannot be controlled with antihypertensive therapy or for hypertensive crisis.

Cardiac Failure: CABOMETYX can cause severe and fatal cardiac failure. Cardiac failure occurred in 0.5% of patients treated with CABOMETYX as a single agent, including fatal cardiac failure in 0.1% of patients. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Withhold and resume at a reduced dose upon recovery or permanently discontinue depending on the severity.

Diarrhea: CABOMETYX can cause diarrhea and it occurred in 62% (10% Grade 3) of treated patients. Monitor and manage patients using antidiarrheals as indicated. Withhold CABOMETYX until improvement to ≤ Grade 1; resume at a reduced dose.

Palmar-Plantar Erythrodysesthesia (PPE): CABOMETYX can cause PPE and it occurred in 45% of treated patients (13% Grade 3). Withhold CABOMETYX until PPE resolves or decreases to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab in RCC can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone. With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Monitor liver enzymes before initiation of treatment and periodically. Consider more frequent monitoring as compared to when the drugs are administered as single agents. Consider withholding CABOMETYX and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Withhold CABOMETYX and/or nivolumab and resume CABOMETYX at a reduced dose depending on severity.

Proteinuria: Proteinuria was observed in 8% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. For Grade 2 or 3 proteinuria, withhold CABOMETYX until improvement to ≤ Grade 1 proteinuria; resume CABOMETYX at a reduced dose. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): CABOMETYX can cause ONJ and it occurred in <1% of treated patients. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures. Withhold CABOMETYX for development of ONJ until complete resolution; resume at a reduced dose.

Impaired Wound Healing: CABOMETYX can cause impaired wound healing. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): CABOMETYX can cause RPLS. Perform evaluation for RPLS and diagnose by characteristic finding on MRI any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Thyroid Dysfunction: CABOMETYX can cause thyroid dysfunction, primarily hypothyroidism, and it occurred in 19% of treated patients (0.4% Grade 3). Assess for signs of thyroid dysfunction prior to the initiation of CABOMETYX and monitor for signs and symptoms during treatment.

Hypocalcemia: CABOMETYX can cause hypocalcemia, with the highest incidence in DTC patients. Based on the safety population, hypocalcemia occurred in 13% of CABOMETYX patients (2% Grade 3 and 1% Grade 4).

Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold and resume CABOMETYX at a reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, and constipation.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong or Moderate CYP3A4 Inducers: If coadministration with strong or moderate CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

Pediatric Use: Physeal widening has been observed in children with open growth plates when treated with CABOMETYX. Physeal and longitudinal growth monitoring is recommended in children (12 years and older) with open growth plates. Consider interrupting or discontinuing CABOMETYX if abnormalities occur. The safety and effectiveness of CABOMETYX in pediatric patients less than 12 years of age have not been established.

Please see accompanying full Prescribing Information View Source

(Press release, Exelixis, MAY 30, 2026, View Source [SID1234666245])

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])

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 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported results from the ENZAMET trial presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. The analysis demonstrates that the Decipher Prostate test identifies which men with metastatic prostate cancer benefit from adding the chemotherapy docetaxel to standard hormonal therapy (ADT plus enzalutamide), known as triplet therapy, and who can safely avoid it, providing the first Level 1B 1 evidence for a genomic test guiding this decision. Complementary data presented at the meeting also reinforce Decipher Prostate’s clinical utility in high-risk localized disease.

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Approximately 334,000 men are diagnosed with prostate cancer annually in the United States, including about 30,000 who present with metastatic disease at diagnosis.2, 3 While recent treatment advances have improved outcomes, clinicians still lack precision tools to guide chemotherapy decisions in this setting.

"For the first time, the ENZAMET trial analysis shows that a genomic test can guide the decision to add chemotherapy to standard of care hormonal therapy in metastatic prostate cancer," said Prof. Christopher Sweeney, M.B.B.S., DHS., Lead Investigator, South Australian Immunogenomics Cancer Institute, Adelaide University. "Decipher Prostate identifies which patients benefit from treatment intensification, and which can be safely spared chemotherapy, giving clinicians an actionable, evidence-based answer."

The ENZAMET findings build on prior validation in the STAMPEDE and CHAARTED trials, where Decipher Prostate identified patients most likely to benefit from adding docetaxel to ADT alone. ENZAMET advances that evidence with the first demonstration that the test predicts chemotherapy benefit when added to doublet therapy (ADT plus an ARPI).

Metastatic Disease: Identifying Which Men Benefit from Chemotherapy

The ENZAMET trial is an international, randomized Phase III study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Researchers performed a pre-specified biomarker analysis using the Decipher Prostate test in 634 patients to assess whether the test could predict benefit from adding chemotherapy to standard hormonal therapy with a median follow-up of 5.6 years.

Results showed:

Improved outcomes guided by Decipher Prostate: Patients with higher Decipher scores (>0.85) and high-volume disease who received triplet therapy had clinically meaningful better survival compared to those on standard hormonal therapy alone.
Patients can be spared from chemotherapy: Patients with lower Decipher scores showed no benefit from adding chemotherapy, suggesting it may be safely avoided.
Practice-changing evidence: The treatment-by-biomarker interaction was statistically significant (p=0.043), providing Level 1B evidence for the test’s predictive value.
Overcoming aggressive disease: Patients with higher Decipher scores who received triplet therapy had more aggressive disease features, yet achieved comparable survival to lower-risk patients on doublet therapy, suggesting chemotherapy offset the poor prognostic effects of aggressive disease biology.
Localized Disease: Identifying Which High-Risk Patients Need Treatment Intensification

Complementing the ENZAMET findings, a combined analysis of four mature NRG/RTOG trials presented at ASCO (Free ASCO Whitepaper) 2026 adds to Decipher Prostate’s growing body of evidence into high-risk localized prostate cancer.

Key findings include:

Improved prognostic accuracy: Decipher Prostate significantly improved prognostic accuracy for survival outcomes compared to clinical variables alone.
Refined risk classification: Combining NCCN clinical risk classification with Decipher Prostate reclassified approximately 1 in 4 patients.
Expanded population for treatment intensification: Results also show many more clinically high-risk patients may benefit from intensification with ARPI.
"Decipher Prostate is the most validated transcriptomic test across the full prostate cancer continuum – from active surveillance through metastatic disease," said Elai Davicioni, Ph.D., Veracyte’s Medical Director, Urology. "For clinicians, that means a clearer answer at every decision point. For patients, it means greater confidence that their treatment is guided by the biology of their disease, and not guesswork."

(Press release, Veracyte, MAY 30, 2026, View Source [SID1234666241])

On May 29, 2026 Alaw Therapeutics, Inc. ("Alaw"), a clinical-stage biotechnology company developing precision oncology therapeutics designed to control oncogenic proliferation, tumor survival, and therapeutic resistance, reported two major pipeline milestones advancing its next-generation cyclin-dependent kinase (CDK) inhibitor portfolio.

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The announcements include:

Dosing of first patients in its Phase 1a/b clinical trial evaluating AL-605, Alaw’s selective, brain-penetrant CDK2 inhibitor, in patients with CCNE1-amplified solid tumors
Drug candidate nomination of AL-433, Alaw’s selective, brain-penetrant CDK4 inhibitor, with first-in-human clinical entry planned for Q4 2026
"These milestones represent an important inflection point for Alaw and for CDK-directed oncology," said Idean Marvasty, President and CFO of Alaw. "The inability to achieve meaningful CNS exposure has remained a fundamental limitation, leaving patients with brain metastases and primary CNS tumors underserved by targeted cell-cycle therapies. AL-605 and AL-433 were specifically engineered to address that challenge through enhanced selectivity of CDK inhibition combined with robust brain penetration."

AL-605: Phase 1a/b Study Initiated for Selective Brain-Penetrant CDK2 Inhibitor

Alaw has initiated a Phase 1a/b clinical trial evaluating AL-605 in patients with cyclin E (CCNE1)-amplified solid tumors. The study is designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, while incorporating prospective biomarker-based patient selection strategies intended to enrich for tumors dependent on CDK2 signaling.

The trial is enrolling two biomarker-defined populations:

Patients with hormone receptor-positive breast cancer that has progressed following CDK4/6 inhibitor therapy and exhibits CCNE1 amplification or overexpression, a setting strongly associated with CDK2-mediated resistance
Patients with CCNE1-amplified solid tumors more broadly, including ovarian, endometrial, gastric, esophageal, and triple-negative breast cancers
The Phase 1a portion follows a standard dose-escalation design, while Phase 1b expansion cohorts are intended to confirm the recommended Phase 2 dose and evaluate early clinical activity. Interim data are anticipated in the second half of 2026.

Addressing a Critical CNS Limitation in CDK2 Therapy

CDK2 inhibition is increasingly recognized as a central strategy for overcoming resistance to CDK4/6 inhibitors, which have transformed the treatment landscape for hormone receptor-positive breast cancer but are ultimately limited by the emergence of CDK2-driven bypass signaling.

However, currently available and emerging CDK2 inhibitors demonstrate limited blood-brain barrier penetration, leaving the CNS as a pharmacologic sanctuary where resistant tumor cells can survive and proliferate. By achieving robust and selective CNS CDK2 inhibition, AL-605 is designed to address both systemic disease and intracranial tumor progression, including brain metastases arising from CDK2-dependent tumors.

Preclinical studies have demonstrated that AL-605 achieves CNS exposure exceeding leading comparator CDK2 inhibitors and produces meaningful antitumor activity in intracranial tumor models, including glioblastoma and triple-negative breast cancer brain metastases.

AL-433: Selective Brain-Penetrant CDK4 Inhibitor Advances Toward First-in-Human Development

Alaw also announced the nomination of AL-433, its selective, brain-penetrant CDK4 inhibitor, as a development candidate, with first-in-human clinical studies planned for Q4 2026.

AL-433 targets tumors driven by dysregulation of the CDK4-cyclin D1-Rb-E2F axis, a central regulator of G1-to-S phase cell-cycle progression frequently altered across aggressive solid tumors.

The program is designed to address two fundamental limitations of the currently approved CDK4/6 inhibitor class:

Selective CDK4 Inhibition. AL-433 was engineered for high selectivity toward CDK4 over CDK6 with the goal of preserving antitumor efficacy while substantially improving tolerability. Reduced CDK6 inhibition may enable uninterrupted dosing and expand combination opportunities with immunotherapies and other targeted agents.
CNS Exposure and Brain Tumor Activity. Approved CDK4/6 inhibitors are substrates for efflux transporters at the blood-brain barrier and achieve minimal CNS exposure, limiting activity against glioblastoma, CDK4-amplified brain tumors, and brain metastases. AL-433 was specifically optimized for brain permeability and is designed to enable clinically meaningful CDK4 inhibition within the CNS.
Preclinical studies demonstrated that AL-433 achieves near-complete blood-brain barrier penetration, resulting in direct intracranial target engagement and antitumor activity in CDK4-dependent CNS tumor models.

AL-433 has been well tolerated in multi-species preclinical safety studies, and GLP toxicology studies are ongoing in support of clinical advancement. Planned clinical studies are expected to permit enrollment of patients with active CNS tumors or brain metastases, a population historically excluded from trials evaluating CDK4/6 inhibitors.

"The convergence of selectivity, brain penetrance, and rational combination strategy is what makes the pipeline fundamentally differentiated," added Marvasty. "We are not developing conventional next-generation CDK inhibitors. We are building the first CDK-directed therapies designed to follow the tumor wherever it goes, including the brain."

About AL-605

AL-605 is a selective, brain-penetrant CDK2 inhibitor designed for the treatment of CCNE1-amplified solid tumors and CDK2-mediated resistance to CDK4/6 inhibitors. The molecule achieves significant CNS exposure and has demonstrated antitumor activity in preclinical intracranial tumor models. AL-605 is currently being evaluated in a Phase 1a/b clinical study.

About AL-433

AL-433 is a selective, brain-penetrant CDK4 inhibitor designed to achieve highly selective inhibition of CDK4 over CDK6 while maintaining near-complete blood-brain barrier penetration. The program is intended to address both the hematologic toxicity and CNS limitations associated with approved CDK4/6 inhibitors and has demonstrated antitumor activity in preclinical CDK4-dependent CNS tumor models, including glioblastoma. Drug candidate nomination has been achieved, and first-in-human clinical studies are planned for Q4 2026.

(Press release, Alaw Therapeutics, MAY 29, 2026, View Source [SID1234666237])