On June 17, 2026 Nectin Therapeutics, a clinical-stage oncology company developing first-in-class immuno-oncology and antibody-drug conjugate (ADC) therapies, reported the presentation of Phase 1a/1b clinical data of NTX1088 in combination with pembrolizumab (Keytruda), Merck’s (known as MSD outside of the U.S. and Canada) anti-PD1 therapy, during an oral presentation at the 2026 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

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The data highlighted NTX1088, a first-in-class monoclonal antibody targeting the poliovirus receptor (PVR; CD155), a key regulator of the DNAM1 axis and an important driver of tumor-mediated immune suppression.

The results were presented from the ongoing Phase 1a/1b, open-label, multicenter, dose-escalation and expansion study, NTX-1088-01 (KEYNOTE E92, NCT05378425), evaluating NTX1088 as both a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors.

A total of 91 patients were treated in the study., and NTX1088 was well tolerated, with no dose-limiting toxicities observed. Based on pharmacokinetics and target occupancy, a dose of 1,750 mg was selected as the recommended dose for expansion.

Preliminary efficacy analysis focused on patients receiving active dose levels of NTX1088 (1200 and 1750 mg) in combination with pembrolizumab (200 mg). Among 41 evaluable patients, confirmed partial responses (PRs) were observed across multiple tumor types, including gastric, bladder, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and melanoma.

The study population represented a particularly challenging treatment setting, with a median of four prior lines of therapy and high rates of prior immune checkpoint inhibitors (CPIs) exposure. Additional patients achieved stable disease, and most responding patients were ongoing at data cutoff with a maximum treatment duration of 24 months.

"These Phase 1 results indicate that NTX1088 in combination with pembrolizumab was well tolerated and demonstrated encouraging preliminary anti-tumor activity in a difficult-to-treat, CPI-pretreated population," said Sarina A. Piha-Paul, M.D., lead Principal Investigator of the NTX-1088-01 study at The University of Texas MD Anderson Cancer Center. "Based on these findings, further clinical evaluation in Phase 2 studies, including in less heavily pretreated and biomarker-enriched cohorts, is warranted."

(Press release, Nectin Therapeutics, JUN 17, 2026, View Source [SID1234668784])

On June 17, 2026 Sonire Therapeutics, a U.S.-based clinical-stage medical device company pioneering non-invasive ultrasound therapies for cancer treatment, reported that Sonire Therapeutics KK, the firm’s Japan-based group company, has been selected for the New Energy and Industrial Technology Development Organization’s (NEDO) Deep-Tech Startups Support Program, which is one of Japan’s largest government-backed initiatives focused on accelerating the commercialization of breakthrough technologies.

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Through NEDO, Sonire has been awarded approximately $13 million in non-dilutive funding to support the advancement of its proprietary High-Intensity Focused Ultrasound (HIFU) therapy platform. The funding will support manufacturing scale-up, regulatory approval activities in Japan, expansion into additional clinical indications, and acceleration of the company’s ongoing U.S. clinical development efforts.

The award reflects the strength of Sonire’s underlying technology and global commercialization strategy, supporting the company’s efforts from research and development through commercialization in both Japan and the U.S. The NEDO program is designed to support promising deep technology companies, and help them bridge the gap between development and commercialization. This provides critical support across the full pathway from product development and regulatory approval through manufacturing and market adoption.

"We are honored to have been selected for NEDO’s DTSU." said Tohru Satoh, President and CEO of Sonire Therapeutics. "At Sonire, we are committed to advancing new treatment options for patients with pancreatic cancer and other difficult-to-treat diseases through our ultrasound therapy platform. This funding will help accelerate our clinical development, regulatory activities, manufacturing readiness, and commercialization efforts in both Japan and the United States, bringing us closer to making this technology available to patients worldwide."

Sonire’s next-generation HIFU therapy system leverages real-time ultrasound guidance to deliver precise, non-invasive tumor ablation, allowing physicians to monitor treatment as it is administered without the need for general anesthesia. The approach is designed to reduce procedural burden while expanding access to pancreatic cancer treatment in outpatient settings, addressing a significant unmet need in a disease where five-year survival remains approximately 13 percent.

The NEDO award follows significant recent momentum for the company, including the initiation of the SUNRISE-II clinical trial in the U.S., $18 million in Series A financing, and the completion of patient enrollment in SUNRISE-I, a randomized controlled trial evaluating the safety and feasibility of Sonire’s HIFU system for pancreatic cancer in Japan. Sonire previously advanced through the STS and PCA phases of the NEDO DTSU Program. The DMP phase represents the program’s most advanced commercialization stage, supporting manufacturing readiness and market preparation activities.

By supporting activities that span development, regulatory approval, manufacturing, and commercialization, the program positions Sonire to accelerate the global adoption of its ultrasound-guided HIFU technology and expand access to minimally-invasive treatment options for patients facing difficult-to-treat cancers.

(Press release, SONIRE Therapeutics, JUN 17, 2026, View Source [SID1234668783])

On June 17, 2026 10x Genomics, Inc. (Nasdaq: TXG), the life science technology leader focused on accelerating science and advancing human health, reported a research collaboration with Cleveland Clinic, a nonprofit multispecialty academic medical center that integrates clinical care with research and education, to advance research in novel diagnostics for bladder cancer.

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This collaboration is part of 10x’s broader efforts to partner with leading research institutions to generate the evidence needed to support the future development of diagnostic applications across oncology and other disease areas.

Through this multi-year collaboration, the study intends to initially examine tumor samples from patients with advanced bladder cancer undergoing emerging therapeutic regimens using 10x’s Flex Apex and Xenium platforms, with the goal of expanding to the recently announced Atera platform. The research aims to identify clinically relevant biomarkers that may help predict bladder cancer patient response to treatment and support future diagnostic development across tumor types.

Bladder cancer remains a complex and heterogeneous disease, with variable responses to therapies such as antibody-drug conjugates and immunotherapies. A major challenge in oncology is determining which therapies are most likely to benefit individual patients. By integrating single cell and spatial analysis, the research aims to generate a more comprehensive understanding of tumor biology and the tumor microenvironment, including features that may influence treatment response and resistance, which remain difficult to characterize using conventional approaches.

"We look forward to collaborating with 10x Genomics on this promising work. This collaboration has the potential to shed new light into the mechanisms underlying therapeutic response in a number of major cancer types," said Timothy Chan, MD, PhD, Chair, Department of Cancer Sciences, Cleveland Clinic.

The study is expected to include tumor samples from patients treated with antibody-drug conjugates and immunotherapy and to integrate single-cell transcriptomic profiling, spatial gene expression and protein measurements. Researchers plan to analyze tumor microenvironment composition, immune cell infiltration and expression of therapeutic targets to better understand mechanisms of response and resistance.

"One of the central challenges in oncology today is understanding why patients respond differently to the same therapy," said Serge Saxonov, Co-founder and CEO of 10x Genomics. "There is a clear need for biomarkers that can guide treatment decisions, and we believe Flex Apex, Xenium and now Atera are uniquely suited to uncover them. These insights will be critical to enabling a new generation of diagnostic approaches in oncology."

The collaboration is expected to generate a comprehensive, multimodal dataset linking single cell and spatial insights with clinical outcomes, helping to advance the scientific understanding of treatment response in bladder cancer and support future diagnostic applications.

(Press release, Cleveland Clinic , JUN 17, 2026, View Source [SID1234668782])

On June 17, 2026 Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab-axgb), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin-piiq) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy. The FDA is expected to make a decision on approval by February 9, 2027.

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The sBLA acceptance is based on results from the Phase III SUNMO study. At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination demonstrated a 59% reduction in risk of disease progression or death (progression-free survival [PFS]) compared to Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx) (hazard ratio 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001) and a three-times longer median PFS at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1). The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines. The incidence of cytokine release syndrome events (CRS) in the Lunsumio VELO plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events.

Updated data were presented recently at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) Congress, which showed that with longer follow-up, this treatment combination continued to demonstrate clinical benefit in PFS, particularly in the second-line setting, with no new safety signals.

"Relapsed or refractory large B-cell lymphoma is an aggressive disease thereby representing one of the highest unmet needs in lymphoma care," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "If approved, this Lunsumio/Polivy combination could provide an important chemotherapy-free, outpatient-ready option to help improve outcomes in this setting."

"When treating large B-cell lymphoma, the second-line setting represents a critical window where we must act quickly with effective therapies," said Tara M. Graff, D.O., M.S., Director of Clinical Research at Mission Cancer and Blood. "Current advanced therapies may present complex logistical and geographical barriers for many patients. Since most patients in the U.S. are treated in the community setting, we need more chemotherapy-free, outpatient-ready treatments, like Lunsumio and Polivy."

LBCL, composed predominantly of DLBCL, is the most common type of non-Hodgkin lymphoma with more than 18,000 new diagnoses each year in the U.S. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Because this stage of disease is time-sensitive, delays caused by referral requirements, inpatient coordination, or comple treatment logistics can have meaningful clinical consequences.

"Navigating relapsed or refractory large B-cell lymphoma can be challenging, particularly for patients who do not live near a major academic center," said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. "The potential new Lunsumio VELO and Polivy combination may address this critical access issue by offering treatment options closer to where a patient lives. It fills a gap in care for people who can’t afford to travel far distances or for long periods of time for treatment."

Lunsumio is part of Genentech’s industry-leading CD20xCD3 bispecific antibody program. It is designed with the unique needs and preferences of patients in mind, offering the possibility of outpatient treatment and flexibility between intravenous (IV) and subcutaneous administration routes. Lunsumio IV and Lunsumio VELO are approved for people with third-line or later follicular lymphoma (FL). Lunsumio holds the most extensive long-term data for any bispecific antibody in lymphoma. Ongoing development of Lunsumio in combination with other treatments includes the Phase III CELESTIMO and MorningLyte studies in second-line or later and frontline FL, respectively.

About the SUNMO study

The SUNMO study [NCT05171647] is a Phase III, randomized, open-label, multicenter trial evaluating the efficacy and safety of Lunsumio VELO (mosunetuzumab-axgb) in combination with intravenously administered Polivy (polatuzumab vedotin-piiq) versus Rituxan (rituximab) plus gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed or refractory large B-cell lymphoma who have received at least one prior systemic therapy and are ineligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes.

About Large B-cell Lymphoma (LBCL)

Large B-cell lymphomas, composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cell. DLBCL is a highly aggressive and life-threatening disease. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. While existing intensive standard-of-care treatments exist, structural, geographical, and clinical access barriers mean that many patients — particularly those in rural communities or receiving care outside of specialized academic transplant centers — face significant burdens and inequities in obtaining timely treatment. Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.

About Lunsumio VELO (mosunetuzumab-axgb)

Lunsumio VELO is a subcutaneous formulation of mosunetuzumab-axgb, a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications.

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.

Lunsumio and Lunsumio VELO U.S. Indication

LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments.

It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

Important Safety Information

What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting

Due to the risk of CRS, you will receive LUNSUMIO or LUNSUMIO VELO on a "step-up dosing schedule."

The step-up dosing schedule is when you receive smaller "step-up" doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment
If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the "step-up dosing schedule"
You may receive medicines to help reduce your risk of CRS before your dose
Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO or LUNSUMIO VELO, if you have severe side effects.

What are the possible side effects of LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including:

Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO or LUNSUMIO VELO, including:
headache
numbness and tingling of the arms, legs, hands, or feet
dizziness
confusion and disorientation
difficulty paying attention or understanding things
forgetting things or forgetting who or where you are
trouble speaking, reading or writing
sleepiness or trouble sleeping
tremors
loss of consciousness
seizures
muscle problems or muscle weakness
loss of balance or trouble walking
tiredness
Serious infections. LUNSUMIO or LUNSUMIO VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO or LUNSUMIO VELO, including:
fever of 100.4°F (38°C) or higher
cough
chest pain
tiredness
shortness of breath
painful rash
sore throat
pain during urination
feeling weak or generally unwell
Hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO or LUNSUMIO VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
fever
enlarged spleen
easy bruising
low blood cell counts
liver problems
Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts:
low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and neutropenia). Low white blood cells can increase your risk for infection
low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
Growth in your tumor or worsening of tumor-related problems (tumor flare). LUNSUMIO or LUNSUMIO VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO or LUNSUMIO VELO:
chest pain
cough
trouble breathing
tender or swollen lymph nodes
pain or swelling at the site of the tumor

Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO or LUNSUMIO VELO if you develop severe side effects.

The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).

The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.

The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.

The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels.

Before receiving LUNSUMIO or LUNSUMIO VELO, tell your healthcare provider about all of your medical conditions, including if you:

have ever had an infusion reaction after receiving LUNSUMIO
have an infection or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. LUNSUMIO or LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO or LUNSUMIO VELO
Females who are able to become pregnant:

your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO
use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving LUNSUMIO or LUNSUMIO VELO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide and LUNSUMIO VELO full Prescribing Information and Medication Guide and on View Source

Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL). Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication

Side effects seen most often

The most common side effects during treatment were

Nerve problems in arms and legs
Nausea
Tiredness or lack of energy
Diarrhea
Constipation
Hair loss
Redness and sores of the lining of the mouth, lips, throat, and digestive tract
Polivy may lower your red or white blood cell counts and increase uric acid levels.

Polivy may not be for everyone. Talk to your doctor if you are

Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and visit View Source for additional Important Safety Information.

(Press release, Genentech, JUN 17, 2026, View Source [SID1234668779])

On June 17, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported positive updated safety and efficacy results from the RAMP 205 Phase 1b/2a Recommended Phase 2 Dose (RP2D) cohort of 29 patients evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma (PDAC).

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KRAS is mutated in more than 90% of pancreatic cancers, making it a key driver of tumor growth. The RAMP 205 trial was designed to evaluate whether simultaneous inhibition of KRAS-driven signaling and FAK-mediated resistance pathways, in combination with standard-of-care chemotherapy, could improve outcomes for patients living with metastatic pancreatic cancer.

"The updated data from the RAMP 205 trial provide important clinical insights into the potential impact of combined RAF/MEK and FAK inhibition as a therapeutic option for pancreatic cancer. While pancreatic cancer remains one of the most challenging cancers to treat, the early survival trends and deep responses observed in this study indicate that avutometinib and defactinib are combinable with standard-of-care chemotherapy and may help overcome resistance mechanisms inherent in pancreatic cancer and support further exploration of strategies designed to address oncogenic signaling and mechanisms of treatment resistance," said John Hayslip, M.D., chief medical officer at Verastem Oncology. "We are grateful to PanCAN, the RAMP 205 investigators, and especially the patients and families who participated in the trial."

In the Phase 1b/2a study, 29 patients were enrolled and treated at the RP2D with avutometinib 2.4 mg twice weekly (BIW), defactinib 200 mg twice daily (BID) for 3 weeks on and one week off, and gemcitabine (800 mg/m2) plus nab-paclitaxel (125 mg/m2) administered on Days 1, 8, and 15 of each 28-day cycle. At diagnosis, 90% of patients presented with metastatic disease. As of the June 5, 2026 data cutoff, with a median follow up of 9.8 months, the combination demonstrated encouraging clinical activity, including an 86% overall survival (OS) rate at 6 months, with the OS data continuing to mature. The progression-free survival (PFS) rate at 6 months was 68%, and the confirmed objective response rate (ORR) was 52% (15/29). At the RP2D dose, the majority (83%) of patients experienced tumor shrinkage. Nine patients remain on treatment at this dose level. Adverse events remained generally consistent with the previously reported safety and tolerability profile, with no new safety signals observed.

"For patients and their families facing a pancreatic cancer diagnosis, every advance in research and understanding of the underlying biology driving this cancer matters," said Anna Berkenblit, M.D., chief scientific and medical officer of the Pancreatic Cancer Action Network (PanCAN). "We awarded Verastem the PanCAN Therapeutic Accelerator Award in 2022 to invest in research and development of novel treatment approaches. The results of the RAMP 205 trial underscore the importance of continued research in the RAS/MAPK-pathway to help improve outcomes for patients living with pancreatic cancer."

"We will continue to evaluate the potential role of avutometinib plus defactinib in metastatic pancreatic cancer, including future development opportunities and potential strategic collaborations, informed by the final overall survival results from the study as well as emerging data from VS-7375, our investigational potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, currently being evaluated in metastatic pancreatic cancer as both a monotherapy and in combination regimens," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We will also assess opportunities to share these data in the future, including at a medical meeting".

In May 2022, Verastem Oncology was selected by PanCAN to receive the inaugural PanCAN Therapeutic Accelerator Award, supporting evaluation of avutometinib in combination with defactinib in front-line metastatic pancreatic cancer. Designed to accelerate the development of new pancreatic cancer treatments, the award provided Verastem with $3.8M following a rigorous, competitive process involving scientific, business, and programmatic review from leading experts in the field. In parallel, a working group led by PanCAN was formed as a partnership between Verastem and the academic community to further understand the science behind and the potential of this investigational treatment combination to improve outcomes for patients.

About Metastatic Pancreatic Cancer

Pancreatic cancer is the third leading cause of cancer-related death in the U.S. and seventh leading cause of cancer-associated mortality worldwide. Metastatic pancreatic cancer, or stage IV disease, occurs when the cancer spreads beyond the pancreas to distant organs. More than 90% of pancreatic cancers harbor KRAS mutations, underscoring the central role of KRAS in the development and the progression of the disease. Approximately 40% of pancreatic tumors harbor a KRAS G12D mutation, the most prevalent subtype in pancreatic cancer. Patients with KRAS G12D-mutant tumors often have poorer outcomes, underscoring the need for therapies designed specifically to inhibit this mutation potently and for a long duration. Each year, more than 30,000 people in the U.S. and over 240,000 people globally are diagnosed with metastatic pancreatic cancer. There has been minimal progress with treatment, and the five-year survival rate remains approximately 3%. Current treatment approaches may include surgery, chemotherapy, radiation therapy, targeted therapies, or a combination of these modalities.

About RAMP 205 Phase 1b/2a Study

RAMP 205 is a multicenter, open-label, single arm Phase 1b/2a study to evaluate the safety, tolerability, and efficacy of avutometinib and defactinib in combination with standard of care chemotherapy (gemcitabine and nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. Part A of the study evaluated varied dose and schedule combinations to determine the recommended Phase 2 dose for expansion into Part B. RAMP 205 is supported by a PanCAN Therapeutic Accelerator Award.

About AVMAPKI and FAKZYNJA Combination Therapy

AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib plus defactinib with standard-of-care chemotherapy as a potential treatment in the first-line for patients with advanced pancreatic cancer (RAMP 205; NCT05669482). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication

Indication

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

· Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity.

· Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration.

· Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality.

· Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction.

· Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Adverse Reactions

The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

· Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.

· Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.

· Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin.

· Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid.

Use in Specific Populations

· Lactation: Advise not to breastfeed.

· Fertility: May impair fertility in males and females.

(Press release, Verastem, JUN 17, 2026, View Source [SID1234668778])