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])

On May 21, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported the presentation of safety and efficacy data from the ongoing EVEREST-2 clinical study (NCT06051695). The findings, which are being presented in poster presentations during the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place May 29 – June 2, 2026, in Chicago, include updates on the first reported complete response (CR) in a patient with non-small cell lung cancer (NSCLC) following treatment with A2B694, a logic-gated mesothelin (MSLN)-targeted TmodTM chimeric antigen receptor T-cell (CAR T-cell) therapy.

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Complete responses have rarely been observed in studies of CAR T-cell therapies for the treatment of solid tumors, and to date none has been reported in patients with lung cancer.1

"We are encouraged by the EVEREST-2 study data being presented during ASCO (Free ASCO Whitepaper) 2026, including updated results for the first reported complete response to CAR T-cell therapy in a patient with a hard-to-treat case of non-small cell lung cancer. These findings support the potential for logic-gated therapies, such as A2B694, to treat solid tumors. We eagerly await the results from A2B543, the armored version of A2B694, which has the potential for greater potency without compromising safety," said Salman R. Punekar, M.D., assistant professor of medicine, NYU Langone Health, Perlmutter Cancer Center and treating physician of the patient.

EVEREST-2 Study Arm 1: Efficacy and Safety Update for A2B694

As of January 5, 2026, 13 patients were enrolled in phase 1: eight women and five men, with a median age of 59 years; 11 were non-Hispanic White and two were Hispanic/unknown race. Tumor types included ovarian (n = 3), pancreatic (n = 3), NSCLC (n = 1), colorectal (n = 4), gastro-esophageal (n = 1), and mesothelioma (n = 1). A2B694 dose groups were 1×108 (n = 3), 2×108 (n = 4), 4×108 (n = 5), and 6×108 plus low-dose IL-2 (n = 1) cells.

Lymphodepletion prior to administration of A2B694 was well-tolerated by all patients, with expected transient cytopenias. All patients had at least one adverse event; all adverse event terms were reported in one patient each, except for grade 3 neutropenia, which was reported in two patients. One patient had grade 3 ICANS managed with corticosteroids and one patient had grade 1 CRS confounded by IL-2 administration. There were no dose-limiting toxicities or new safety signals after up to 17 months of follow-up. No deaths were attributed to A2B694, and no patient has discontinued the study due to adverse events.

One patient with co-mutated (KRAS G12V/STK11) NSCLC, a subtype associated with resistance to chemoimmunotherapy and poor prognosis, had progressed on standard-of-care first-line treatment of carboplatin, pemetrexed, and pembrolizumab before enrolling in EVEREST-2. At month 3 post-infusion of A2B694, the patient achieved a complete response (CR) per RECIST 1.1 and had a confirmed CR by central review at month 6 as well as a PET-CT scan which showed no evidence of disease. At month 8, the patient had an isolated CNS relapse, with an ongoing non-CNS CR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) at month 9. At 15 months, the patient’s CT showed no new findings, and persistence of A2B694 in the blood was confirmed by ddPCR.

EVEREST-2 Study Arm 2: Enrollment Update on A2B543

An additional presentation from the EVEREST-2 study is a trials-in-progress poster about A2B543, a CAR T-cell therapy which uses the same logic-gated construct as A2B694, armored with the addition of a membrane-tethered IL-12 (mem-IL-12) booster.

IL-12 is a potent, pro-inflammatory cytokine that plays a crucial role in inducing antitumor immune responses; however, systemic IL-12 can be prohibitively toxic. In A2B543, expression of the mem-IL-12 cassette is under the control of an NFAT promoter and is induced during antigen engagement or T cell activation. This inducible mem-IL-12 is designed to reduce the toxicity associated with systemic IL-12 while enhancing the long-term potency and persistence of TmodTM. The first A2B543 patient was enrolled to dose level 1 in January 2026, and dose escalation continues. A2B543 has received Fast Track Designation from the FDA.

A third A2 Bio poster presentation during ASCO (Free ASCO Whitepaper) 2026 describes modules based on IL-12 and other molecules that boost potency and preserve selectivity of TmodTM-based precision cell therapies.

Poster Presentation Details

Abstract Title

Presenting Author

Abstract Number

Poster Board Number

Poster Presentation Date/Time

Poster Session

Initial safety and efficacy of A2B694, a logic-gated mesothelin (MSLN)-targeted Tmod chimeric antigen receptor T-cell (CAR T) therapy in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH)

Julian R. Molina, M.D., Ph.D.

Mayo Clinic
Rochester, Minn.

8579

369

Sunday, May 31, 2026

9:00 AM-12:00 PM CDT

Lung Cancer—Non- Small Cell Metastatic

A logic-gated chimeric antigen receptor T-cell (CAR T) therapy with an armored, membrane-tethered IL-12 booster in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH): EVEREST-2, a Phase 1/2 study

Salman R. Punekar, M.D.

NYU Langone Health
New York

TPS2673

459a

Saturday, May 30, 2026

1:30 PM-4:30 PM CDT

Developmental Therapeutics— Immunotherapy

Influence of onboard, tethered IL-12 on potency of the Tmod NOT gate and selectivity

Jushen Liang

A2 Biotherapeutics
Agoura Hills, Calif.

2562

352

Saturday, May 30, 2026

1:30 PM-4:30 PM CDT

Developmental Therapeutics— Immunotherapy

Full abstracts are available online on the ASCO (Free ASCO Whitepaper) website.

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added mem-IL-12 booster. The EVEREST-2 study is recruiting patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

Invented at A2 Bio, the TmodTM platform is a precision-targeting cellular system, designed with logic-gate technology to enable immune cells to unequivocally differentiate tumors from normal tissues. The system consists of activator and blocker receptors. The activator recognizes antigens on tumor cells and triggers their destruction, while the blocker recognizes antigens on normal cells and protects them. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

(Press release, A2 Biotherapeutics, MAY 21, 2026, View Source [SID1234665974])

On May 21, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, reported extended follow-up data out to three years from the Phase 1/1b study of ficerafusp alfa in combination with pembrolizumab in first-line (1L) recurrent/metastatic (R/M) human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). The data, which included the 750mg weekly (QW), 1500mg QW, and 2000mg every-other-week (Q2W) expansion cohorts, demonstrated deep, durable responses observed to be driven by TGF-β inhibition. The data will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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Ficerafusp alfa is a bifunctional epidermal growth factor receptor (EGFR)-directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap designed to enable increased tumor penetration to drive deep and durable responses and potentially improve survival outcomes. Bicara is currently evaluating ficerafusp alfa at 1500mg QW in combination with pembrolizumab in the Phase 3 portion of the ongoing FORTIFI-HN01 pivotal study. Additionally, the company plans to initiate a study evaluating a 12-week loading dose followed by a 2250mg every-three-weeks maintenance dose regimen in the third quarter of 2026 to support long-term administration.

"Ficerafusp alfa continued to deliver deep, durable responses with up to three years of follow-up in 1L R/M HPV-negative HNSCC, reinforcing its best-in-class potential in this setting. At our pivotal study dose of 1500mg QW, an estimated one in three patients was alive at three years – approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients," said Bill Schelman, M.D., Ph.D., Chief Medical Officer of Bicara Therapeutics. "TGF-β inhibition was observed to be the mechanistic foundation of this clinical benefit: driving tumor penetration, enabling immune cell infiltration, and translating depth of response into durable, long-term survival – a clinical profile no other EGFR-directed therapy in head and neck cancer has demonstrated."

Up to three years of follow-up reinforces ficerafusp alfa’s best-in-class potential in 1L R/M HPV-negative HNSCC

Across all dose cohorts of ficerafusp alfa in combination with pembrolizumab, the data demonstrated deep, durable responses and a generally well-tolerated safety profile. All three dose cohorts also demonstrated clinically meaningful duration of response (DOR), progression-free survival (PFS) and overall survival (OS), representing substantial improvements over standard of care treatment.

Notably, complete response (CR) rates have continued to mature across all three cohorts since prior data presentation – increasing to 13% at 750mg QW, 25% at 1500mg QW, and 30% at 2000mg Q2W as of the March 31, 2026 data snapshot.

Additionally, deep responses of at least 80% tumor shrinkage were observed at doses of ficerafusp alfa that resulted in greater TGF-β inhibition and tumor penetration, with more than three-fourths of responders in the 1500mg QW and 2000mg Q2W cohorts achieving deep responses.

Three-year follow-up from the 1500mg QW dose cohort, as of the March 31, 2026 data snapshot, showed an estimated OS rate of 31%, approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients.1

Table 1. Key Efficacy Results Across Ficerafusp Alfa Dose Cohorts in Combination with Pembrolizumab in 1L R/M HPV-Negative HNSCC

750mg QW
(n=30) 1500mg QW
(n=28) 2000mg Q2W
(n=27)
Confirmed overall response rate 57% 54% 48%
CR rate 13% 25% 30%
Deep (≥80%) responses 47% 80% 77%
Median time to response 1.6 months 1.4 months 1.6 months
Median DOR NR (>16.6 months) 21.7 months NR (>12.8 months)
Median PFS 6.9 months 9.9 months 12.7 months
Median OS NM (>19.4 months) 21.3 months NM (>12.7 months; >23.6 months in patients with > 2-year follow-up)*
Data snapshot as of March 31, 2026. NR = not reached; NM = not mature
*Data maturation reflects a bimodal enrollment distribution: in the initial 15 efficacy evaluable patients (median follow-up: 27 months) median OS is not mature but has surpassed 23.6 months. The remaining 12 efficacy evaluable patients had a median follow-up of 11.7 months.

TGF-β inhibition drove depth and durability of response

Biomarker analyses across all three dose cohorts demonstrated sustained TGF-β inhibition and immune activation with ficerafusp alfa, reinforcing the mechanistic link between intra-tumoral TGF-β inhibition, immune activation, and the deep, durable responses.

Deep responses translated to improved durability and long-term outcomes for patients

Ficerafusp alfa’s depth of response, as demonstrated by CR rates and proportion of deep responders, has been well-established and is clinically differentiating. The updated data further reinforced depth of response as a driver of long-term outcomes in patients with 1L R/M HPV-negative HNSCC. Across a pooled cohort analysis, two-thirds of responders achieved deep responses of greater than 80% tumor shrinkage and experienced more durable disease control, with meaningfully longer DOR, PFS, and OS compared to patients with partial responses of less than 80% tumor shrinkage.

Across the pooled analysis comparing deep responders to partial responders of less than 80% tumor shrinkage, deep responders demonstrated:

A median DOR of 31.6 months;
A median PFS of 36.9 months, with a 65% reduction in the risk of ​disease progression or death; and
A median OS that has not been reached, with a ​63% reduction in the risk of death.
This updated dataset provides compelling evidence for depth of response as a clinical surrogate for differentiated long-term outcomes with ficerafusp alfa treatment.

ASCO 2026 Poster Presentations
Annual Meeting | Chicago, IL | May 30 – June 3, 2026

Poster 1 (Wong et al.): Sustained Depth and Durability of Response with TGF-β Trapping in 1L R/M HPV-Negative HNSCC
Sustained depth and durability of response with TGF-β trapping in recurrent or metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC): Long-term results from two expansion cohorts of a phase 1/1b study of ficerafusp alfa plus pembrolizumab
Authors: Wong DJ, et al. | Abstract #6040 | Poster Board: 497 | May 30, 2026, 1:30-4:30 p.m. CDT

Poster 2 (Kaczmar et al.): Impact of Depth of Response on Long-Term Clinical Outcomes
The impact of depth of response on long-term clinical outcomes: Exploratory analyses from multiple expansion cohorts of a phase 1/1b study of ficerafusp alfa plus pembrolizumab in first-line recurrent/metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC)
Authors: Kaczmar J, et al. | Abstract #6058| Poster Board: 515 | May 30, 2026, 1:30-4:30 p.m. CDT

Poster 3 (Ferrarotto et al.): FORTIFI-HN01 Trial in Progress
A multicenter, randomized, double-blind, phase 2/3 study of ficerafusp alfa (BCA101) or placebo in combination with pembrolizumab for first-line treatment of PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma: FORTIFI-HN01
Authors: Ferrarotto R, et al. | Abstract #TPS6129| Poster Board: 584A | May 30, 2026, 1:30-4:30 p.m. CDT

1. Based on a retrospective analysis of Supplementary Figure 1C, Vasiliadou, Ifigenia, et al. International Journal of Cancer 155.5 (2024): 883-893. No head-to-head studies have been conducted, and cross-trial comparisons differences in molecule composition, trial design, and patient population and characteristics.

Conference Call Information
Bicara will host a live conference call and webcast on Friday, May 22, 2026 at 8:30 a.m. ET. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

About Head and Neck Squamous Cell Carcinoma
Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are diagnosed with metastatic disease and up to 30% develop a recurrence or metastases over time after receiving initial treatment for advanced HNSCC. Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately 80% of patients with R/M HNSCC are HPV-negative. These HPV-negative tumors often exhibit a recurrence pattern that is primarily local and are associated with severe morbidities, including fatal tumor bleeding, intense pain, difficulty swallowing, significant weight loss, and cachexia. This highlights a critical unmet need for therapies that have the potential to deliver durable anti-tumor responses, ultimately leading to meaningful improvements in patients’ quality of life.

About Ficerafusp Alfa
Ficerafusp alfa is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC.

(Press release, Bicara Therapeutics, MAY 21, 2026, View Source [SID1234665990])

On May 20, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, reported that C4T management will participate in the upcoming conferences.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TD Cowen 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper)

Management will participate in a virtual fireside chat on May 26, 2026, at 2:30 pm ET.

2026 Jefferies Global Healthcare Conference

Management will participate in a fireside chat on June 3, 2026, at 8:45 am ET, taking place in New York, New York.

Goldman Sachs 47th Annual Global Healthcare Conference

Management will participate in 1×1 meetings on June 10, 2026, taking place in Miami, FL.

The live webcasts will be available on the Investors section of the company’s website at www.c4therapeutics.com. Archived replays of the webcasts will be available for approximately 90 days following the events.

(Press release, C4 Therapeutics, MAY 20, 2026, View Source [SID1234665891])