On May 22, 2025 Volastra Therapeutics, a clinical-stage cancer biotechnology company focused on chromosomal instability, reported preliminary safety and efficacy data from its ongoing, first-in-human Phase I/II trial of its novel, oral KIF18A inhibitor, VLS-1488 (Press release, Volastra Therapeutics, MAY 22, 2025, View Source [SID1234653320]). These results will be featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Monday, June 2.

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"We are excited by these results from our VLS-1488 KIF18A inhibitor program, demonstrating a favorable safety profile at clinically active doses, with tumor shrinkage in patients with heavily pre-treated ovarian cancer" said Scott Drutman, M.D., Ph.D., Chief Medical Officer and Head of R&D of Volastra Therapeutics. "These initial data represent a major milestone for the field of chromosomal instability and provide a clear path for dose and patient population selection for the next phase of development."

As of the January 10, 2025 data cutoff, 52 patients with advanced solid tumors were enrolled to the dose escalation portion of the trial across dose levels ranging from 50 mg to 800 mg. Drug exposures exceeded preclinically-defined efficacious thresholds for anti-tumor activity. No dose limiting toxicities were observed and a maximum tolerated dose was not reached. Less than 45% of patients experienced treatment-related adverse events (TRAEs) of any grade and less than 16% of all patients experienced G3 TRAEs. No patients experienced >G3 TRAEs.

Of the 20 patients with advanced high grade serous ovarian cancer, the majority were platinum resistant and heavily pretreated with a median of 5 prior lines of therapy. At the time of data cutoff, 7 of the 17 response-evaluable patients demonstrated a reduction in tumor size, including 3 Partial Responses per RECIST, with 5 patients remaining on therapy.

"These early data show VLS-1488 to be very well tolerated, with promising initial efficacy in ovarian cancer." said Ecaterina Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and investigator on the trial. "The data that will be presented demonstrate the potential of KIF18A as a novel, relevant therapeutic target for hard-to-treat cancers and I look forward to continued development."

Volastra continues to enroll patients in this study and explore the broad potential of its two KIF18A inhibitors, VLS-1488 and sovilnesib in ovarian and other cancers.

Details of the ASCO (Free ASCO Whitepaper) Rapid Oral Abstract Session are as follows:
Title: Preliminary results from a first-in-human, phase I/II study of VLS-1488, an oral KIF18A inhibitor, in patients with advanced solid tumors
Presenter: Ecaterina Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology – Small Molecules
Session Date and Time: Monday, June 2, 2025, 8:00 AM- 9:30 AM CT
Location: McCormick Place Convention Center, S406
About VLS-1488

VLS-1488 is a novel, oral small molecule inhibitor of KIF18A, a kinesin protein essential for cancer cell division and a synthetic lethal target in chromosomally unstable cancers. VLS-1488 was granted Fast Track Designation from the FDA in October 2024 for the treatment of patients with platinum-resistant high-grade serous ovarian cancer.

About VLS-1488-2201 Trial (NCT05902988)

The Phase 1/2 trial is evaluating the safety, tolerability, PK, and antitumor activity of VLS-1488 in patients with advanced solid tumors, including high grade serious ovarian cancer. The study consists of two parts, Dose Escalation and Dose Expansion. Enrollment to the dose expansion portion of this study is ongoing.

About Ovarian Cancer and Chromosomal Instability

In the U.S. alone, there are more than 20,000 new cases of ovarian cancer each year, over 75% of which are advanced. Most of these patients will experience disease progression on platinum-based therapy.

High grade serous ovarian cancer accounts for approximately 75% of all ovarian cancers, about 80% of all deaths and is almost universally chromosomally unstable.

On May 22, 2025 Foresight Diagnostics, Inc. ("Foresight"), a leading diagnostics company specializing in the development of ultra-sensitive minimal residual disease (MRD) detection, reported the presentation of independent validation data demonstrating the prognostic performance of its Foresight CLARITY MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) (Press release, Foresight Diagnostics, MAY 22, 2025, View Source [SID1234653336]). The results will be shared in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 31 to June 3, 2025, in Chicago, Illinois.

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The prospective, multi-center observational study, led by Amsterdam UMC in close collaboration with the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON) and Netherlands Comprehensive Cancer Organization (IKNL), is the largest independent validation study of Foresight CLARITY to date, spanning more than 150 patients with frontline DLBCL treated uniformly with curative-intent therapy across 50 sites in the Netherlands and Belgium.

Key Findings:

ctDNA-MRD was detected at end of treatment (EOT) in 24% of patients; 76% were MRD-negative.
MRD-positive patients showed significantly lower progression-free survival (28% vs. 88%) and overall survival (50% vs. 97%) compared to MRD-negative patients.
Among patients who were MRD-negative and achieved PET complete response at EOT, 2-year progression-free survival (PFS) and overall survival (OS) were 91% and 99%, respectively.
All patients who failed to achieve complete response by PET and remained MRD-positive experienced relapse.
ctDNA-MRD remained a powerful independent predictor of outcomes across multiple clinical subgroups, even after adjusting for standard prognostic factors.
"These results provide important prospective validation of Foresight CLARITY’s clinical performance in frontline DLBCL across a large, real-world patient cohort," said David Kurtz, M.D., Chief Medical Officer of Foresight Diagnostics. "This study adds to a growing body of clinical evidence that we believe should strengthen the field’s confidence in our assay’s ability to accurately assess treatment response. We remain on track for a planned launch into the clinical market and look forward to integrating CLARITY into routine clinical practice."

Lead study authors Steven Wang, M.D. and Martine Chamuleau MD PhD, Amsterdam UMC, added: "Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL."

Oral presentation details:

Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial
Presenter: Steven Wang, MD, PhD (Amsterdam UMC)
Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Time: Friday, May 30 | 2:45 – 5:45 p.m. CT
Location: Room S100a or live stream for virtual attendees
Abstract number: 7000
In addition to the oral presentation, Foresight’s technology will be highlighted in other presentations, including:

"Sequencing-guided chemotherapy optimization using real-time evaluation in newly diagnosed DLBCL with circulating tumor DNA: SHORTEN-ctDNA" (NCT06693830) Presenter: Stephanie Meek, Ph.D. (Foresight) in collaboration with Columbia University
Type: Poster #272a
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A

"ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy"
Sponsor: Allogene Therapeutics
Presenter: Jason Westin, M.D., M.S., FACP (The University of Texas MD Anderson Cancer Center)
Type: Poster #267a
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A
"Safety and Efficacy of AZD0486, a CD19xCD3 T-cell Engager, in Relapsed or Refractory Diffuse Large B-cell Lymphoma" (NCT04594642)
Sponsor: AstraZeneca
Presenter: Tae Min Kim, M.D. (Seoul National University Hospital)
Type: Poster #229
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A
"Circulating tumor DNA assessment in patients with early-stage classical Hodgkin lymphoma treated with combination of brentuximab vedotin and nivolumab" (NCT03646123)
Sponsor: Pfizer
Presenter: Ryan Lynch, M.D. (Fred Hutchinson Cancer Center)
Type: Poster #223
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A

On May 22, 2925 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, has dosed the first patient in its one-year extension of the ongoing phase 2 trial with its lead asset EVX-01 (Press release, Evaxion Biotech, MAY 22, 2025, View Source [SID1234653291]). Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

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The extension will further explore the full potential of EVX-01 as a possible new and innovative treatment of advanced melanoma, particularly its long-term clinical and immune benefits. The trial extension involves minimal cost as trial sites are running and the vaccine product has already been produced.

Having completed the initial two-year treatment, the first patient in the extension of the trial has now received the first additional dose of EVX-01. Patients entering the one-year extension of the trial will in total receive two additional EVX-01 doses as monotherapy.

In the first two years of the trial, EVX-01 was administered in combination with standard anti-PD-1 therapy (checkpoint inhibitors). With checkpoint inhibitor treatment restricted to a two-year duration, the extension phase provides an opportunity to evaluate the benefits of EVX-01 monotherapy. This could position EVX-01 as a potential standalone treatment for advanced melanoma.

"Extending the trial allows us to explore EVX-01’s potential beyond its combination use with checkpoint inhibitors. By studying EVX-01 as a monotherapy, we aim to assess the independent effects of EVX-01, including its induced immune response and clinical outcome. Given that checkpoint inhibitor therapy is not approved beyond two years of treatment, this additional EVX-01 treatment option could offer a meaningful option for patients", says Birgitte Rønø, Chief Scientific Officer of Evaxion.

EVX-01 is designed with Evaxion’s AI-Immunology platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Convincing one-year phase 2 data
Initially planned to run for two years, the trial remains on track to yield two-year data for presentation in the second half of 2025. Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013).

Further, 80% of EVX-01’s vaccine targets triggered a targeted immune response, as presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2025. This number compares very favorably to what is seen with other approaches.

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.

On May 22, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, reported publication of cell therapy NXC-201 Abstract #7508, selected for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2025) being held in Chicago, Illinois (Press release, Immix Biopharma, MAY 22, 2025, View Source [SID1234653306]). The abstract summarizes positive results from the U.S. multi-site NEXICART-2 trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis with a data cutoff of January 28, 2025.

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On June 3, 2025 Heather Landau, MD of Memorial Sloan-Kettering Cancer Center in New York will present further updated results at ASCO (Free ASCO Whitepaper) oral presentation in Chicago, IL. A Key Opinion Leader (KOL) event to discuss the significance will be held Tuesday, June 3, 2025 3:00pm ET with live Q&A (register here to participate).

"We are beyond thrilled with the strength of these results. I believe these results could transform the paradigm of relapsed/refractory AL Amyloidosis treatment," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "Recent NXC-201 FDA RMAT designation and ASCO (Free ASCO Whitepaper) interim readout demonstrate our progress toward completion of NEXICART-2 enrollment and BLA submission."

Immix’s Phase 1/2 NEXICART-2 clinical trial is a U.S. multi-site, single-arm study to evaluate the efficacy and safety of NXC-201 in patients who are refractory to, or relapse on treatment for relapsed/refractory AL Amyloidosis.

ASCO Abstract Results
Prior to NXC-201 treatment, the median lines of therapy was 4 (range: 2-9). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement. After NXC-201 treatment, all patients normalized pathological disease markers. Complete responses (CRs) were observed in 71% (5 out of 7) of patients treated with NXC-201. The remaining 2 patients are bone marrow minimum residual disease (MRD) negative (10-6), predicting future CR (Immix believes remaining two MRD negative (10-6) patients could be confirmed as CRs in the coming weeks and months). Downstream clinical improvement, including cardiac and renal organ responses, were recorded after CRs. There have been no relapses recorded to-date and no safety signals identified. No neurotoxicity has been observed. Only low-grade cytokine release syndrome has been observed, lasting less than 24 hours. The ASCO (Free ASCO Whitepaper) abstract contains clinical data as of January 28, 2025.

Current treatments typically result in a lower than 10% complete response (CR) rate in relapsed/refractory AL Amyloidosis according to Zanwar, et al 2024, indicating a high unmet medical need.

Updated NXC-201 results with a later data cutoff, including endpoint analysis, will be presented on June 3, 2025 by lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center:

Upcoming ASCO (Free ASCO Whitepaper) Presentation

Title "Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201"
Presentation
Date/Time
Session Date: Tuesday, June 3, 2025 at 12:09pm CT (1:09pm ET)
Abstract Number: 7508
Session Name: 652. Oral Abstract Session – Hematologic Malignancies-Plasma Cell Dyscrasia
KOL Event to Discuss NXC-201 ASCO (Free ASCO Whitepaper) Clinical Data Presentation
A Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD of Cleveland Clinic and Jeffrey Zonder, MD of Karmanos Cancer Center will be held subsequently Tuesday, June 3, 2025 at 3:00 pm ET to discuss these results. Register here: View Source

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

On May 22, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported interim clinical data as of a February 27, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab (Press release, Merus, MAY 22, 2025, View Source [SID1234653321]). These data will be presented by Dr. Carla M. L. van Herpen M.D. Ph.D., Radboud University Medical Center, Nijmegen, Netherlands at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Monday, June 2 at 9 a.m. – 12:00 p.m. CT.

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"By essentially every metric, we believe these interim data are significantly better than pembrolizumab monotherapy, the control arm of our ongoing phase 3 trial, and underscores the opportunity petosemtamab holds to become a new standard of care, if approved, in head and neck cancer," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Additionally, we believe our execution is outstanding with rapid site initiation. We are looking forward to potentially sharing top line interim readout of one or both of our phase 3 trials in 2026."

"Head and neck squamous cell carcinoma is associated with a poor prognosis and high mortality rate, and there remains a need for new treatment options for patients," added Dr. van Herpen. "In my clinic, I have witnessed firsthand profound tumor shrinkage with petosemtamab administration, and the efficacy results petosemtamab has shown thus far in combination with the current standard of care, pembrolizumab. I’m excited by the impressive ORR and durability of those responses, and what these results, if replicated more broadly could mean for the future of our practice in head and neck cancer."

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors

Presentation title: Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of PD-L1+ recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial

Observations in the presentation include as of a February 27, 2025 data cutoff date:

45 patients (pts) were treated
The efficacy evaluable population consisted of 43 patients who were treated (with one or more doses) as of the data cutoff date and either ≥1 post-baseline tumor assessment, or discontinued early due to disease progression or death
Median follow up of 14.3 months for the 45 patients
In 43 evaluable patients:
Confirmed overall response rate: 63% (27/43, 95% CI: 49-75), including 6 complete responses, 21 partial responses by Response Evaluation Criteria in Solid Tumors v1.1. per investigator assessment, including:
4 of 8 patients with HPV associated cancer responded
Responses observed across PD-L1 levels (CPS 1-19: 47% [8/17]; CPS > 20: 73% [19/26])
Median progression-free survival was 9 months (95% CI: 5.2-12.9)
Median duration of response and median overall survival (OS) were not reached
79% overall survival rate at 12-months (30/43 censored)
At the time of data cutoff, 14 patients, each of whom are responders, remained on treatment
In 45 patients the combination was generally well tolerated and no significant overlapping toxicities with pembrolizumab were observed
Treatment-emergent adverse events (TEAEs) were reported in 45 pts
G≥3 TEAEs occurred in 27 (60%) patients, including 20 (44%) patients who experienced treatment-related TEAEs
Infusion-related reactions (composite term) were reported in 38% of patients (all Gs) and 7% (G3), no G4 or 5, mainly occurred during the first infusion and were resolved
Abstract #: 6024
Poster Board: 432
Session Title: Head and Neck Cancer
Session Date and Time: June 2, 2025, 9:00-12:00 CT

As full presentations become available at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, they will contemporaneously be available on the Merus website.

An analysis of the confirmed responses observed from administration of petosemtamab across the first line combination (as of the February 27, 2025 data cutoff date) and second-line plus monotherapy phase 2 cohorts (as of the July 5, 2024 data cutoff date), demonstrated that two-thirds of these responses with petosemtamab in HPV-associated p16+ oropharyngeal cancer occurred in never-smokers.

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Thursday, May 22, 2025 at 5:30 p.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.
Date & Time: May 22, 2025 at 5:30 p.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: (800) 715-9871 / International: (646) 307-1963
Conference ID: 7517301 or Merus NV call