On May 21, 2026 Physician-scientists from Rutgers Cancer Institute and RWJBarnabas Health reported that it will present practice-changing research and emerging treatment approaches across a range of cancer types at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2 in Chicago and online. Highlights include findings from a late-breaking abstract, Neo-adjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial, scheduled for presentation on June 1 at 10:45 a.m. CDT.

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Rutgers Cancer Institute, New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, together with RWJBarnabas Health, will have a significant presence at this year’s meeting with 39 accepted peer-reviewed scientific abstracts, including one late-breaking session and a combination of oral and poster presentations, a clinical science symposium, an education session and panel Q&A.

"Advances in cancer care are increasingly defined by how effectively we can translate scientific discovery into meaningful impact for patients," said Steven K. Libutti, MD, FACS, William N. Hait Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "The research being presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting reflects the expertise and leadership of our world-class physician-scientists and multidisciplinary teams, whose work continues to advance innovation in cancer care. From early detection to novel therapies and clinical insights, we are leveraging data, technology and collaboration to deliver more personalized and accessible care for patients. Building on the capabilities of the Jack & Sheryl Morris Cancer Center, New Jersey’s only freestanding cancer hospital, we are creating greater opportunities for patients to access the latest treatments, clinical trials and specialized cancer care closer to home."

The research accepted for presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting exemplifies the breadth and impact of our oncology program and includes studies across breast, colorectal, pancreatic, and other cancer types.

Key scientific contributions from Rutgers Cancer Institute and RWJBarnabas Health at ASCO (Free ASCO Whitepaper) 2026:

ABSTRACT 7009: Researchers reported results from Part 1B of the Phase 3 OLYMPIA-3 study evaluating odronextamab (ODRO) plus Chemotherapy (CHOP) in patients with previously untreated diffuse large B-cell lymphoma with high-risk features. Among 40 patients randomized to two dosing regimens, the safety profile was generally manageable and similar across groups. Findings show encouraging preliminary efficacy with no meaningful differences between regimens, and the less frequent dosing schedule was selected as the recommended Phase 3 dose for the next stage of the study.

EDUCATION SESSION: Researchers reviewed the evidence and rationale for the early integration of palliative care (EPC) alongside disease-directed treatment in patients with metastatic castration-resistant prostate cancer. EPC is delivered by an interdisciplinary team and focuses on symptom management, psychosocial support, communication and shared decision-making, and future planning, including advance care planning. The review highlights evidence showing that early palliative care can improve quality of life, reduce symptom burden, improve mood, and reduce aggressive end-of-life care. The authors also note that prostate cancer’s long disease trajectory and cumulative treatment-related morbidity make it especially suited to early palliative involvement.
ABSTRACT 7093: A multivariable analysis of overall survival was conducted from the Phase 3 SUNMO, STARGLO, and POLARGO trials in patients with relapsed/refractory large B-cell lymphoma and evaluated combination therapies versus rituximab plus chemotherapy. The analyses showed that after adjusting for baseline differences, all three studies demonstrated favorable overall survival with adjusted hazard ratios ≤0.65 versus rituximab plus chemotherapy. The pooled analysis further supported the overall survival benefit of mosunetuzumab plus polatuzumab vedotin compared with the control treatment.

ABSTRACT 12038: The HERO trial evaluated Tai Chi Qigong (TCQ) for its effects on fatigue-related gene expression profiles compared with an exercise-intensity matched intervention and usual care. Among the 113 participants, TCQ favorably regulated genes involved in inflammation, metabolite sensing, and energy activation pathways at 3 months. These findings suggest that TCQ produced meaningful changes in inflammatory, adrenergic, energy and metabolic pathways, supporting potential biological mechanisms behind its effects on cancer-related fatigue.
The full list of presentations from Rutgers Cancer Institute and RWJBarnabas Health at this year’s 2026 ASCO (Free ASCO Whitepaper) Annual Meeting can be found here.

(Press release, Rutgers Cancer Institute of New Jersey, MAY 21, 2026, View Source [SID1234665957])

On May 21, 2026 Researchers from City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, reported it will present new findings at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where the cancer center will showcase 49 abstracts spanning solid tumors and blood cancers.

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This year’s research, to be presented in Chicago from May 29 to June 2, reflects growing efforts to tailor cancer treatment based on tumor biology, prior therapies and patient-specific factors that influence response.

"Cancer care is entering a new phase where understanding the biology of each patient’s disease is just as important as the treatment itself," said Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive. "The research we are presenting at ASCO (Free ASCO Whitepaper) demonstrates how precision medicine is becoming a reality across cancer types, and how we can use that insight to deliver smarter therapies, improve outcomes and move the field forward."

City of Hope featured oral presentations

4519: Gut microbiome patterns linked to response to immunotherapy in advanced kidney cancer
7007: Targeted antibody combination shows improved outcomes in patients with relapsed large B-cell lymphoma (SUNMO study subgroup analysis)
4015: Experimental therapy targeting a key cancer growth pathway in advanced liver cancer
5014: First-in-human study of a novel targeted therapy for advanced prostate cancer
Microbiome insights may help predict immunotherapy benefit in kidney cancer

City of Hope researchers report that gut microbiome composition may influence how patients respond to immunotherapy combinations in metastatic renal cell carcinoma, pointing to a potential biomarker that could help guide treatment selection in the future.

The microbiome is a rising focus at City of Hope, highlighted by a recent symposium that convened federal health leaders and top cancer centers to accelerate progress in the field.

The study findings come from a combined analysis of two randomized phase 1 trials evaluating standard-of-care immune checkpoint inhibitor regimens with or without the addition of CBM5881, a live biotherapeutic designed to modulate the gut microbiome. The trials enrolled treatment-naïve patients with metastatic disease who received either nivolumab plus ipilimumab or nivolumab plus cabozantinib, reflecting commonly used immunotherapy-based frontline options.

Across the combined dataset, patients who received CBM588 in addition to immunotherapy achieved an objective response rate of 66.7%, compared with 20% among those receiving standard therapy alone. Median progression-free survival improved to 32.1 months with the combination versus 3.7 months with standard treatment.

Researchers also used a metagenomic measure called TOPOSCORE to assess gut imbalance and found that patients with a more disrupted microbiome saw the greatest benefit. In this subgroup, progression-free survival increased from 2.8 months to 24.9 months with the addition of CBM588. The association between microbiome profile and treatment response was particularly evident in patients who received nivolumab plus ipilimumab, suggesting that the microbiome may interact differently depending on the immunotherapy backbone.

The new data support a growing body of research linking the gut microbiome to immune response.

"These findings suggest the microbiome may play a direct role in shaping immunotherapy outcomes," said Rahul Winayak, M.D., postdoctoral fellow at City of Hope. "If validated in larger studies, this approach could help guide treatment decisions and improve outcomes for patients with kidney cancer."

A randomized phase 3 trial is underway to further evaluate this strategy.

Bispecific antibody combination improves outcomes for patients with lymphoma, including in earlier lines of therapy

Updated data from the phase 3 SUNMO trial continue to show that the combination of mosunetuzumab, a bispecific antibody, and polatuzumab vedotin, an antibody-drug conjugate, improves outcomes for patients with relapsed or refractory large B-cell lymphoma who are not eligible for autologous stem cell transplant.

The study randomized patients to receive the combination regimen or standard chemotherapy with rituximab, gemcitabine and oxaliplatin. With a median follow-up of more than two years, the combination demonstrated an objective response rate of 70.3%, compared with 40.0% for standard therapy, along with a significant reduction in the risk of disease progression.

A key focus of this updated analysis was outcomes by line of therapy. Among patients who received treatment in the second-line setting, the combination produced higher response rates, deeper remissions and longer durations of response compared with both later-line patients and those who received chemotherapy. Median progression-free survival and duration of complete response were not reached in several subgroups, underscoring the durability of benefit.

The safety profile remained stable with longer follow-up, with low rates of higher-grade cytokine release syndrome and no observed neurotoxicity. These findings support use of this novel regimen in patients who are unable to tolerate aggressive chemotherapy.

"These results support the growing role of bispecific antibody-based combinations as an alternative to traditional chemotherapy," said Elizabeth Budde2, M.D., Ph.D., executive medical director of the Enterprise Immune Effector Cell Program at City of Hope. "We are especially encouraged by the durability of responses in earlier lines of therapy, where improving long-term outcomes is critical for every patient."

New therapy targeting a key cancer growth pathway shows promise in advanced liver cancer

City of Hope investigators are evaluating tegavivint, a first-in-class small-molecule inhibitor that targets the Wnt/β-catenin signaling pathway, a key driver in many liver cancers that have historically been difficult to treat.

The ongoing phase 1/2 study includes patients with advanced hepatocellular carcinoma who have received at least one prior line of systemic therapy and have disease that cannot be treated with surgery or localized therapies.

Among patients with Wnt pathway mutations detected with molecular profiling and treated within the recommended dose range, the therapy demonstrated clinical activity, with an objective response rate of 22%, disease control rate of 89% and median progression-free survival of eight months in patients treated earlier in their disease course.

Importantly, the study showed evidence of target engagement, including reductions in alpha-fetoprotein levels and changes in Wnt pathway circulating tumor DNA allele frequency. These findings suggest that the drug is affecting the intended biological pathway, a key challenge in prior efforts to target Wnt signaling.

"Targeting the Wnt pathway has long been a major challenge in oncology, but these data suggest we may finally be making progress," said Daneng Li, M.D., gastrointestinal medical oncologist at City of Hope. "With further validation, this approach could meaningfully expand treatment options and provide a potential targeted therapy approach to improve outcomes for patients with advanced liver cancer."

First-in-human study shows early activity for novel prostate cancer therapy

City of Hope researchers are presenting early results from a first-in-human study of ABBV-969, a dual-targeting antibody-drug conjugate that binds PSMA and STEAP1, two proteins commonly found in advanced prostate cancer. The therapy is designed to deliver a potent anti-cancer agent directly to tumor cells expressing PSMA and/or STEAP1 antigens.

The phase 1 study enrolled patients with metastatic castration-resistant prostate cancer who had received multiple prior lines of therapy, including androgen receptor pathway inhibitors and taxane-based chemotherapy to stop cell division. Patients were treated across a range of dose levels to evaluate safety, pharmacokinetics and preliminary efficacy.

Among patients with measurable disease, the therapy achieved an objective response rate of 45%, with responses observed across multiple dose levels starting at 3 mg/kg. Reductions in prostate-specific antigen (PSA) levels were also common, with 67% of patients achieving a PSA50 response and 28% achieving deeper PSA declines of 90% or greater.

The study assessed a range of doses and dose optimization is ongoing. The study also demonstrated a manageable safety profile. The most common higher-grade adverse events were hematologic, including anemia, which were generally reversible and consistent with the drug’s mechanism of action.

"We are seeing early signals that this targeted approach can deliver meaningful responses, even in heavily pretreated patients," said Tanya Dorff3, M.D., F.A.S.C.O., genitourinary medical oncologist at City of Hope. "The next step will be to better understand how to position this therapy to further improve outcomes."

(Press release, City of Hope, MAY 21, 2026, View Source [SID1234665973])

On May 21, 2026 Asher Biotherapeutics (Asher Bio), a clinical-stage biotechnology company developing precisely-targeted immunotherapies for cancer, reported two upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026 in Chicago.

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The presentations will include updated clinical data from the phase 1A/B study of AB248, Asher Bio’s investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, alone and in combination with pembrolizumab in patients with advanced solid tumor malignancies, as well as a trials-in-progress report from the ongoing phase 1 study of AB821, Asher Bio’s CD8-targeted interleukin-21(IL-21) immunotherapy candidate, in patients with locally advanced or metastatic melanoma and other solid tumor malignancies.

"AB248 and AB821 were each designed to address historical limitations of cytokine therapy by selectively activating CD8+ T cells while avoiding the broader immune activation associated with conventional cytokines," said Ivana Djuretic, Ph.D., chief executive officer and co-founder of Asher Bio. "Together, these programs are designed to selectively deliver complementary IL-2 and IL-21 biology to CD8+ T cells, with the goal of providing the proliferative and functional signals needed to drive potent antitumor immunity. Updated data to be presented at ASCO (Free ASCO Whitepaper) continue to support the differentiated profile of AB248, with robust and selective CD8+ T-cell expansion, encouraging antitumor activity in a heavily pretreated melanoma population and a tolerability profile that supports further evaluation. In addition, the evaluation and trial design for AB821 highlight the broader potential of our CD8-targeted cytokine platform, including the potential to use these drugs in combination with each other."

AB248 (Etakafusp alfa)

As of the most recent data cutoff, AB248 demonstrates robust and dose-dependent pharmacologic activity, including preferential CD8+ T cell expansion of approximately 20-fold at higher dose levels. Importantly, this magnitude of CD8+ T cell expansion was achieved without vascular leak or a capillary leak-driven toxicity pattern, a key distinction from high-dose systemic IL-2, where capillary leak syndrome is a recognized dose-limiting toxicity. Across the phase 1A/B study, the most common treatment-emergent adverse events were predominantly grade 1 or 2 and self-limited.

Additionally, AB248 demonstrates anti-tumor activity in patients with immune checkpoint inhibitor-refractory melanoma. In the monotherapy arm, deep and durable responses were observed in two out of 11 patients with cutaneous melanoma treated at higher dose levels (0.3 – 0.5 mg/kg), representing an 18% objective response rate (ORR). In the combination arm with pembrolizumab, seven of 30 patients with IO doublet-refractory melanoma treated with 0.15 – 0.3 mg/kg AB248 achieved an objective response, including 30% of patients treated at 0.3 mg/kg. Activity was observed across melanoma subtypes, including cutaneous melanoma and more difficult-to-treat forms of the disease, such as mucosal and acral melanoma. A maximum tolerated dose (MTD) was not reached with step-up dosing, supporting further evaluation of dose optimization, including the potential to evaluate higher doses.

"These data are particularly encouraging given that patients enrolled in the melanoma cohorts had received extensive prior immunotherapy, including prior checkpoint inhibitor doublets," said Harriet Kluger, M.D., Harvey and Kate Cushing Professor of Medicine (Oncology) and of Dermatology at Yale School of Medicine and chief of the Skin and Kidney Cancer Program at Smilow Cancer Hospital at Yale New Haven. "The observation of responses across cutaneous, mucosal and acral melanoma supports continued development of AB248 in combination with anti-PD-1 therapy, including additional dose optimization and expansion."

AB821

Asher Bio will also present the trial design from the ongoing phase 1 study of AB821, an investigational CD8-targeted IL-21 immunotherapy candidate designed to selectively deliver IL-21 activity to CD8+ T cells. The ongoing study is evaluating AB821 as monotherapy in patients with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. Preliminary findings from approximately 10 patients enrolled to date suggest promising pharmacokinetic, pharmacodynamic, tolerability and clinical activity. Emerging results are consistent with preclinical data, including evidence of cis-targeting and pharmacodynamic effects on CD8+ T cells. An amendment evaluating AB821 in combination with AB248 is in development.

"Together, these presentations highlight an important step in advancing our CD8-targeted cytokine portfolio from platform biology into clinical translation," said Edward Garmey, M.D., interim chief medical officer of Asher Bio. "The AB248 data continue to inform dose optimization and combination strategies for CD8-targeted IL-2, while the initial AB821 findings provide an early clinical view of CD8-targeted IL-21. Looking ahead, we are particularly interested in exploring how these complementary cytokine signals may be used individually and potentially together to deepen and extend antitumor responses while maintaining tolerability."

ASCO 2026 Presentation Details

Title: Phase 1A/B study of AB248, a CD8+ selective IL-2 mutein fusion protein, alone or in combination with pembrolizumab, in patients with advanced solid tumor malignancies
Abstract Number: 2616
Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board: 406
Date and Time: Saturday, May 30, 2026, 1:30 – 4:30 p.m. CDT

Title: Phase 1 clinical trial investigating the safety, pharmacokinetics, pharmacodynamics and antitumor activity of AB821 in adult patients with locally advanced or metastatic melanoma and other solid tumor malignancies
Abstract Number: TPS2687
Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board: 466a
Date and Time: Saturday, May 30, 2026, 1:30 – 4:30 p.m. CDT

For more information on these and other abstracts, please visit the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting website.

About AB248
AB248 is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T cells, which are the immune cells that drive antitumor efficacy, while avoiding natural killer cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T cells, which are immunosuppressive. Asher Bio is evaluating AB248 in a phase 1A/B clinical trial, AB248-101. The trial consists of a dose escalation and expansion phase to investigate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of AB248 alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. AB248 is also being evaluated in combination with IMDELLTRA (tarlatamab), Amgen’s DLL3-targeting Bispecific T-cell Engager (BiTE) therapy, in an Amgen-sponsored phase 1b trial in patients with extensive-stage small cell lung cancer (ES-SCLC). Please refer to ClinicalTrials.gov, NCT05653882 and NCT07037758, for additional details related to these clinical trials.

About AB821
AB821 is a CD8-targeted IL-21 immunotherapy candidate designed to selectively activate CD8+ T cells, the immune cell type driving antitumor response. AB821 is a fusion protein combining a CD8+ T-cell targeting antibody with a modified IL-21 cytokine designed to prevent binding to other cell types that may drive toxicity or act as a pharmacological sink. In preclinical studies, AB821 enhanced CD8+ T-cell cytotoxicity and memory formation, with potential to reinvigorate exhausted immune responses and generate new antitumor activity, both as monotherapy and in combination with checkpoint inhibitors. AB821 is being evaluated in an ongoing phase 1 clinical trial in patients with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors.

(Press release, Asher Biotherapeutics, MAY 21, 2026, View Source [SID1234665989])

On May 21, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported a 17.3-month median overall survival (OS) in first-line metastatic pancreatic cancer patients treated in its Phase 2a clinical trial evaluating atebimetinib (IMM-1-104) plus modified gemcitabine/nab-paclitaxel (mGnP), as of the April 24, 2026 data cutoff date. The only treatment-related adverse events observed at Grade 3 or higher in ≥10% of patients were anemia (16%) and neutropenia (18%), both chemotherapy-related. The full data (N=55) including details on OS, progression free survival (PFS), response, safety, weight stability/gain, and other relevant information will be shared in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by Peter Vu, MD, MHA of UC San Diego Health, on June 1, 2026, at 1:15 p.m. CDT.

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"In my own patients on this trial, I have seen meaningful benefit without the functional decline I am accustomed to seeing in this disease — patients holding their weight, their energy, and their sense of themselves across many months of treatment," said Daniel Ahn, D.O., Mayo Clinic Arizona, an investigator on the Phase 2a trial of atebimetinib. "When the field has more than one effective first-line option, the deciding factor at the bedside will be tolerability."

"A 17.3-month median overall survival is a meaningful result for first-line metastatic pancreatic cancer patients," said Ben Zeskind, Ph.D., CEO of Immuneering. "Importantly, only two categories of Grade 3 or higher treatment-related adverse events were observed in 10% or more of patients, both chemotherapy-related. These findings support our randomized Phase 3 clinical trial, MAPKeeper 301, which is now recruiting. We look forward to Dr. Vu’s presentation of the full data at ASCO (Free ASCO Whitepaper) on June 1."

The company will share data from the expanded cohort totaling 55 first-line patients at ASCO (Free ASCO Whitepaper) on June 1, 2026, which includes an initial cohort of 34 patients that the company previously reported, plus an additional 21 patients. The company’s pivotal Phase 3 MAPKeeper 301 (NCT07562152) trial of atebimetinib + mGnP in patients with first-line metastatic pancreatic cancer is currently recruiting, and the company is on track to dose the first patient in mid-2026.

Oral Presentation Details:

Title: Results from a phase 2a study of atebimetinib in combination with mGnP in advanced or metastatic pancreatic cancer
Session Type/Title: Rapid Oral Abstract Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4013
Date and Time: June 1, 2026, 1:15 p.m. – 2:45 p.m. CDT
Presenter: Peter Vu, M.D., MHA (UCSD)

Authors: Vincent Chung (City of Hope), Peter Vu (UCSD), Vincent Ma (University of Wisconsin), Nataliya Uboha (University of Wisconsin), Umair Majeed (Mayo Clinic), Su Chandra (Northwestern), Devalingam Mahalingam (Northwestern), Melissa Johnson (Sarah Cannon), Meredith Pelster (Sarah Cannon), Anna Pavlick (Weill Cornell), Allyson Ocean (Weill Cornell), Barbara Ma (Weill Cornell), Alex Spira (NEXT Oncology), Steven Duffy (HOACNY), Jason Henry (Sarah Cannon), Gregory Botta (UCSD), Alexander Philipovskiy (Sarah Cannon), Shubham Pant (MD Anderson), Sant Chawla (Sarcoma Oncology), Jenny Zhang (Immuneering), Jason Kim (Immuneering), Sarah Kolitz (Immuneering), Jason Funt (Immuneering), Vinny Hayreh (Immuneering), Brett Hall (Immuneering), Ben Zeskind (Immuneering), Igor Matushansky (Immuneering), Daniel Ahn (Mayo Clinic)

Conference Call

Immuneering will host a conference call and live webcast at 8:00 a.m. ET / 7:00 a.m. CT on June 1, 2026, to discuss the data. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S callers and (646) 307-1963 for other locations and reference conference ID 7597768, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com. A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

(Press release, Immuneering, MAY 21, 2026, View Source [SID1234665942])

On May 21, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global, single-arm ALKOVE-1 Phase 1/2 clinical trial, and preliminary data in patients with advanced ROS1-positive solid tumors other than NSCLC from the global, single-arm ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1-selective inhibitor, to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.

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"The pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC enabled our recent NDA submission to the FDA, and represent important progress toward our goal of offering a new treatment option for this patient population," said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. "Collectively, these data as well as preliminary data from the TKI-naïve cohort of our ALKOVE-1 study are supportive of further investigation of neladalkib in the global Phase 3 ALKAZAR trial of neladalkib compared to alectinib for TKI-naïve ALK-positive NSCLC, a critical step towards our ultimate goal of moving neladalkib up the treatment paradigm. We look forward to sharing these data with the medical community during an oral presentation at ASCO (Free ASCO Whitepaper), and are deeply grateful to the patients, caregivers, and investigators who have made this milestone possible."

"These data build on the consistent characterization of neladalkib across preclinical and Phase 1 investigations," said Jessica J. Lin, M.D., Program Director of Thoracic Medical Oncology at the Mass General Brigham Cancer Institute, Associate Professor of Medicine at Harvard Medical School, and presenting author. "The data support neladalkib’s potential to deliver on its design goals as an option for patients with ALK-positive NSCLC, including those whose disease progresses with brain metastases or resistance mutations, or who are unable to tolerate the currently available TKIs."

"We also continue to progress the development of zidesamtinib, our ROS1-selective inhibitor, and are pleased to share the preliminary activity observed in patients with ROS1-positive cancers other than NSCLC," said Darlene Noci, A.L.M., Chief Development Officer of Nuvalent. "These data highlight zidesamtinib’s potential for patients with ROS1-positive solid tumors outside of NSCLC, and we believe reinforce the importance of widespread genomic testing. We continue to enroll adult and adolescent TKI-naïve and TKI pre-treated patients with advanced ROS1-positive solid tumors outside of NSCLC in the global Phase 2 portion of our ARROS-1 study, and look forward to providing additional updates in the future."

Pivotal Data for Neladalkib in TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial

Title: ALKOVE-1: Efficacy and safety of neladalkib in patients with advanced ALK+ NSCLC
Presenting Author: Jessica J. Lin, M.D.1
Abstract Number: 8503
Oral Session Title: Lung Cancer—Non-Small Cell Metastatic
Presentation Date and Time: May 29, 2026, 1:00 PM-4:00 PM CDT
Location: Hall D2

The pivotal data to be presented, initially announced in November 2025, are from TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial. In this population, neladalkib demonstrated encouraging overall activity, including intracranial responses, the ability to address key drivers of disease progression, and a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design. These data served as the foundation for the company’s New Drug Application (NDA) submission, announced in April 2026, to the U.S. Food and Drug Administration (FDA) for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.

Preliminary Data for Zidesamtinib in Patients with Advanced ROS1-positive Solid Tumors Other than NSCLC from ARROS-1 Clinical Trial

Title: Zidesamtinib efficacy and safety in patients with advanced ROS1-positive solid tumors other than NSCLC in the ARROS-1 study
Presenting Author: Benjamin Solomon, M.D., Ph.D.2
Abstract Number: 3108
Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Location: Hall A
Poster Board Number: 245

Preliminary data are reported for 15 response-evaluable patients enrolled across 10 solid tumor types outside of NSCLC in the Phase 1 and Phase 2 portions of the ARROS-1 clinical trial as of a data cutoff date of September 22, 2025. The majority (12/15) of patients received the recommended Phase 2 dose of 100 mg once daily. Patients were refractory to standard-of-care therapies (60%, 9/15) or were previously treated with a ROS1 TKI (40%, 6/15), and 73% (11/15) of patients had received prior chemotherapy.

Among all patients with advanced ROS1-positive solid tumors treated with zidesamtinib, an objective response rate of 40% (6/15) was observed, with responses seen for ROS1 TKI-naïve patients refractory to standard-of-care therapies, and for those who had received a prior ROS1 TKI. As of the data cutoff date, four of the six responders remained on treatment with zidesamtinib. Three case studies support zidesamtinib’s potential in a range of treatment settings:

Treatment ongoing for approximately 42 months with partial response in a TKI pre-treated patient with an inflammatory myofibroblastic tumor;
Treatment ongoing for approximately 13 months with partial response in a TKI-naïve patient with metastatic colorectal cancer previously treated with standard of care chemotherapy; and,
Treatment ongoing for approximately 19 months with partial response in a TKI-naïve patient with cholangiocarcinoma previously treated with standard of care chemotherapy.
Among these 15 patients, zidesamtinib was observed to be generally well-tolerated with only one dose reduction due to treatment-related adverse events (TRAEs) and no discontinuations due to TRAEs or treatment-emergent adverse events as of the data cutoff date. The preliminary overall safety profile was consistent with its ROS1-selective, TRK-sparing design, and with previously reported data.

Enrollment is ongoing in the global Phase 2 cohort of the ARROS-1 trial for adult and adolescent patients with advanced ROS1-positive solid tumors other than NSCLC.

About Neladalkib
Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global, single-arm, registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.

(Press release, Nuvalent, MAY 21, 2026, View Source [SID1234665958])