On May 27, 2026 AstraZeneca reported that the US Food and Drug Administration (FDA) has informed that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation.

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The NDA is based on positive results from the pivotal SERENA-6 Phase III trial presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.1 The FDA granted Breakthrough Therapy Designation for the camizestrant combination in this setting in May 2025.

In April 2026, the FDA’s Oncologic Drugs Advisory Committee did not reach a majority vote in favour of the benefit of switching to camizestrant in combination with a CDK4/6 inhibitor after detection of an ESR1 mutation in circulating tumour DNA (ctDNA) prior to radiographic progression, based on the SERENA-6 Phase III trial. Subsequently, the Company has provided additional analyses requested by the FDA in support of the application, including ctDNA clearance data linked to longer-term efficacy outcomes that will be presented on 02 June at ASCO (Free ASCO Whitepaper) 2026.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "We are committed to continuously advancing the clinical landscape in oncology in pursuit of improving outcomes for patients. The SERENA-6 treatment strategy epitomises this approach by monitoring patients for the emergence of ESR1 mutations in ctDNA and testing if a switch of endocrine backbone therapy at this point improves outcomes. We look forward to continuing the dialogue with the FDA in order to bring the benefits of camizestrant with this innovative treatment strategy to eligible patients in the US as quickly as possible."

On 22 May, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of the camizestrant combination in this setting based on the results of the SERENA-6 Phase III trial.

Camizestrant is approved in the United Arab Emirates and Saudi Arabia in this setting. Regulatory applications are also currently under review in Japan and several other countries based on the SERENA-6 Phase III trial.

Notes

HR-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.2 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.2 In the US, breast cancer is the most common cancer in women, with more than 300,000 new cases of the disease diagnosed annually, and more than 42,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.4

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.4 Estrogen receptor (ERs) often drive the growth of HR-positive breast cancer cells.5

Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.6-8 In the US, approximately 37,000 patients with HR-positive metastatic breast cancer are treated with these therapies in the 1st-line setting.6-8 However, resistance to these therapies develops in many patients.8 Once this occurs, treatment options are limited and survival rates are low with approximately 36% of patients anticipated to live beyond five years after diagnosis.4,8

Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.9,10 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.6

The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment.

Camizestrant
Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.

AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer.

Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors.

(Press release, AstraZeneca, MAY 27, 2026, View Source [SID1234666110])

On May 27, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that data from HERIZON-GEA-01 were published in The New England Journal of Medicine and will be presented in an oral presentation (Rapid Oral Abstract: 4010) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 1, 2026, in Chicago. The HERIZON-GEA-01 clinical trial evaluated ZIIHERA (zanidatamab) plus chemotherapy, with and without TEVIMBRA (tislelizumab), compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA).

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Dr. Sun Young Rha, Professor of Medical Oncology at the Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea, senior author of the NEJM manuscript and first author of the ASCO (Free ASCO Whitepaper) abstract, said:

"Results from the HERIZON-GEA-01 published in The New England Journal of Medicine and presented in an oral presentation at ASCO (Free ASCO Whitepaper) provide new data about the regimen of tislelizumab added to zanidatamab plus chemotherapy, which demonstrated meaningfully improved outcomes for patients with HER2-positive gastroesophageal adenocarcinoma. In particular, the findings show that this regimen resulted in a survival benefit, even in patients with PD-L1 <1%. This combination has the potential to be an important new treatment option in areas of high unmet need in HER2+ GEA."

Key findings published in The New England Journal of Medicine

Overall survival (OS): A statistically significant and clinically meaningful improvement in OS with ZIIHERA plus TEVIMBRA and chemotherapy, reaching a median OS of 26.4 months; mOS of 24.4 months was reported with ZIIHERA plus chemotherapy, and 19.2 months with the control arm.
Progression-free survival (PFS): A statistically significant and clinically meaningful improvement in PFS in both ZIIHERA-containing arms with a median PFS of 12.4 months.
Duration of Response (DoR): Median DoR of 20.7 months with ZIIHERA and TEVIMBRA plus chemotherapy; median DoR of 14.3 months with ZIIHERA plus chemotherapy and 8.3 months with the control arm.
Dr. Geoffrey Ku, Associate Attending physician on the Gastrointestinal Oncology Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center, author of the NEJM manuscript and the ASCO (Free ASCO Whitepaper) abstract, said:

"This practice-changing study demonstrates that zanidatamab is clearly superior to trastuzumab, with a manageable safety profile, in HER2-positive GEA. Moreover, the addition of tislelizumab contributes to the prolongation of overall survival and remarkable durability of responses, with benefit in both PD-L1 positive and negative tumors. If approved, the combination of zanidatamab, tislelizumab and chemotherapy should become the standard of care in untreated metastatic or locally advanced HER2-positive GEA patients irrespective of the tumor PD-L1 status."

Oral presentation with new data at ASCO (Free ASCO Whitepaper) 2026 demonstrates benefit regardless of PD-L1 status

With 26 months of follow-up, ZIIHERA plus TEVIMBRA and chemotherapy meaningfully improved PFS and OS were observed in both PD-L1-positive and PD-L1-negative patients compared with the control arm; data were consistent between tumor area positivity (TAP) and combined positive score (CPS).
In PD-L1 TAP <1% and ≥1% patients, the 18-month PFS was 50.3% and 42.6%, respectively, and the 24-month OS was 63.7% and 53.5% with ZIIHERA plus TEVIMBRA and chemotherapy.
In PD-L1-negative patients (TAP <1%), median OS was 29.7 months with ZIIHERA plus TEVIMBRA and chemotherapy compared with 15.8 months with the control arm. In PD-L1-positive patients (TAP≥1%), median OS was 26.4 months with ZIIHERA plus TEVIMBRA and chemotherapy compared with 21.2 months in the control arm. Findings were consistent across PD-L1 assessment methods.
In TAP<1%, the ZIIHERA plus TEVIMBRA and chemotherapy regimen resulted in a mPFS of 18.5 months compared with mPFS of 7.9 months in the control arm, while in TAP≥1% patients, the mPFS was 11.3 months vs. mPFS of 8.3 months in the control arm
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne Medicines, said:

"The HERIZON-GEA-01 results – now published in The New England Journal of Medicine with a detailed sub-group analysis presented in an oral session at ASCO (Free ASCO Whitepaper) – strengthen the evidence supporting the role of TEVIMBRA in driving a sustained and statistically significant overall survival benefit. With a median OS of more than 26 months, unprecedented in this disease, the TEVIMBRA-containing arm is positioned as a compelling new therapeutic approach in a disease where there remains a critical unmet need."

The safety findings for the ZIIHERA plus TEVIMBRA and chemotherapy arm were generally consistent with the known effects of HER2-directed therapy and immunotherapy, and no new safety signals were identified. Diarrhea was the most common Grade ≥3 treatment-related adverse event (TRAE) in 24.5% of patients with ZIIHERA plus TEVIMBRA and chemotherapy, 20.0% of patients in the ZIIHERA plus chemotherapy arm, and 12.9% in the trastuzumab plus chemotherapy arm, noting that the median treatment duration was longest for the triplet arm at 43.1 weeks (vs. 31.0 weeks with ZIIHERA plus chemotherapy and 30.0 weeks in the control arm). A mandatory anti-diarrheal prophylaxis was established during the first cycle, and discontinuation rates due to drug-related diarrhea were relatively low at 4.1%, 1.3%, and 0% of patients, respectively, with most diarrhea events occurring early in the trial.

Regulatory Status

The U.S. FDA has accepted a supplemental Biologics License Applications (sBLA) for TEVIMBRA and has granted it priority review. In addition, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted sBLAs for ZIIHERA and for TEVIMBRA for the first-line treatment of advanced/metastatic HER2+ GEA. BeOne holds the rights to ZIIHERA in Asia (excluding India and Japan), Australia, and New Zealand, and intends to work with authorities in these markets to expedite regulatory submissions.

About the HERIZON-GEA-01 Phase 3 Trial

HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with Jazz Pharmaceuticals, to evaluate and compare the efficacy and safety of ZIIHERA plus chemotherapy, with and without TEVIMBRA, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: ZIIHERA in combination with chemotherapy and TEVIMBRA; ZIIHERA in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About Gastroesophageal Adenocarcinoma

Gastroesophageal adenocarcinoma (GEA), which includes cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide. Approximately 20% of GEA patients have HER2-positive disease.1,2,3, which has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.4

About ZIIHERA (zanidatamab)

ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.5

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved in over 50 countries, and more than 2 million patients have been treated globally.

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see full U.S. Prescribing Information including the U.S. Medication Guide.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, MAY 27, 2026, View Source [SID1234666109])

On May 27, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported that the US Food and Drug Administration (FDA) has granted orphan drug exclusivity for PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS was granted full approval by the FDA in August 2025, becoming the first and only approved treatment for adults with RRP, a rare, chronic and debilitating disease. PAPZIMEOS is commercially available in the US and is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.

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Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug exclusivity granted by the FDA for PAPZIMEOS for the treatment of adults with RRP is effective through August 14, 2032, providing seven years of market exclusivity in the US from the PAPZIMEOS approval date.

"We appreciate the FDA’s recognition of seven years of orphan drug exclusivity for PAPZIMEOS, which is a testament to the groundbreaking pivotal study data and the transformative potential of PAPZIMEOS in addressing the root cause of this rare disease," said Helen Sabzevari, PhD, President and CEO of Precigen. "This regulatory exclusivity, together with Precigen’s patent portfolio covering PAPZIMEOS and its therapeutic use, enhances the product’s value by strengthening market protection and long-term revenue potential, which in turn supports continued innovation for rare diseases."

About RRP
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients’ work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US.

About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only
PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first and only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen’s labs using Precigen’s proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP.

Indication and Important Safety Information

What is PAPZIMEOS?
PAPZIMEOS is a type of immunotherapy used to treat a condition called recurrent respiratory papillomatosis (RRP) in adults.

What is the most important information I should know about PAPZIMEOS?
Some people may have a reaction to the shot. Signs and symptoms may include redness, pain, swelling, itching, or warmth where the shot was given. After your first treatment, your healthcare provider will watch you for at least 30 minutes to make sure you’re feeling okay.

Please contact your doctor immediately if you develop an infection, the reaction to your shot worsens, or you experience any of the below symptoms, which may indicate a systemic allergic reaction:

Difficulty breathing
Widespread rash
Facial swelling
Thrombotic events (blood clots that block your blood vessels) may occur after your PAPZIMEOS shot. Please notify your doctor immediately if you have the following symptoms:

Shortness of breath
Chest pain
Leg swelling
Persistent abdominal pain
Severe or persistent headaches
Blurred vision
What should I know before taking PAPZIMEOS?
Before taking PAPZIMEOS, tell your healthcare provider about all of your medical conditions, including:

If you are pregnant or plan to become pregnant because it is not known if PAPZIMEOS will harm the unborn baby.
If you are breastfeeding or plan to breastfeed. It is unknown if PAPZIMEOS is present in breast milk, or how it affects the breastfeeding child or milk production. Talk to your healthcare provider about the best way to feed your baby during treatment with PAPZIMEOS.
What are the most common side effects of PAPZIMEOS?
The most common side effects include:

Pain, redness, or swelling where the shot was given
Feeling tired
Chills
Fever
Muscle aches
Nausea (feeling sick)
Headache
Increased heart rate
Diarrhea
Vomiting
Sweating a lot
These are not all of the possible side effects of PAPZIMEOS. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777).

(Press release, Precigen, MAY 27, 2026, View Source [SID1234666108])

On May 27, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that its management team is scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 3, 2026, at 8:10 am ET in New York.

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A live webcast of the fireside chat can be accessed under "Events & Presentations" on the Company’s website at www.verastem.com. A replay of the webcasts will be archived on the website for approximately 90 days following the presentation.

(Press release, Verastem, MAY 27, 2026, View Source [SID1234666107])

On May 27, 2026 ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV (Intravenously Deliverable Oncolytic Virus) platform, reported the presentation of clinical data from an investigator-initiated Phase I study of IDOV-Safe, the company’s first clinical-stage oncolytic virus, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

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The poster, titled "Intravenous oncolytic virus IDOV-Safe in pMMR/MSS metastatic colorectal cancer" (Abstract #3536), will be presented on Saturday, May 30th, at Poster Board 290 by Tong Xie, MD, of Peking University Cancer Hospital & Institute in Beijing, China. The study’s principal investigator is Lin Shen, MD, of the same institution.

"These findings validate a core hypothesis underlying our IDOV platform that systemic delivery of an oncolytic virus can prime immune responses even in tumors historically considered immune-cold," said Nanhai George Chen, PhD, Founder and Chief Executive Officer of ViroMissile. "Achieving a 30-46% response rate in pMMR/MSS metastatic colorectal cancer, a setting where checkpoint inhibitors have largely fallen short, represents an encouraging signal that warrants further investigation. We look forward to advancing this approach into our contemplated registrational Phase 2 study."

The data are from a study evaluating IDOV-Safe in combination with fruquintinib, a VEGF inhibitor, and toripalimab, a PD-1 inhibitor, in patients (n=55) with proficient mismatch repair/microsatellite stable (pMMR/MSS) metastatic colorectal cancer (mCRC). Patients with mCRC historically have limited treatment options and poor response to checkpoint inhibitor-based immunotherapy. The poster highlights results from a key expansion cohort (n=20) where treatment with IDOV-Safe demonstrated an objective response rate (ORR) of 30.0% and a disease control rate (DCR) of 70.0%, with a median progression-free survival (PFS) of 8.7 months. In patients without liver metastases, ORR reached 46.2% and median PFS extended to 10.8 months.

Study Design

The investigator-initiated Phase I trial treated a total 55 patients with pMMR/MSS mCRC across all cohorts. The study employed a triplet 3+3 dose-escalation design to assess dose-limiting toxicities (DLTs) and determine the maximum tolerated dose and the recommended expansion dose. Expansion cohorts assessed IDOV-Safe in combination with fruquintinib and with or without toripalimab across three combination strategies: sequential, early, and IO-free. Primary and secondary endpoints included safety, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS).

Key findings

Safety
IDOV-Safe demonstrated a manageable safety profile across all dose levels
62% of patients experienced Grade 3 or higher treatment-related adverse events (TRAEs), with only one Grade 4 TRAE reported as a dose-limiting toxicity (DLT). The most common TRAEs were transient fever, thrombocytopenia, and neutropenia
No treatment-related deaths were observed
Efficacy/Tumor Response
In the sequential combination expansion cohort, which received IDOV-Safe at the higher dose level in combination with fruquintinib and toripalimab, the results demonstrated:
An objective response rate (ORR) of 30.0% was observed overall in the key expansion cohort
In patients without liver metastases, ORR reached 46.2% with a DCR of 84.7% and a median PFS of 10.8 months, compared to a median PFS of 3.7 months in patients with liver metastases
Median progression-free survival (PFS) was 8.7 months overall.
The poster will be available on the ViroMissile website after the conclusion of the session.

(Press release, ViroMissile, MAY 27, 2026, View Source [SID1234666104])