On April 13, 2026 Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology and embolization solutions, reported landmark 12-month results from the DOORwaY90 study, the first pivotal, prospective, multicenter U.S. trial of Y-90 selective internal radiation therapy (SIRT) using partition dosimetry in patients with unresectable hepatocellular carcinoma (HCC).

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The DOORwaY90 study met its prespecified co-primary endpoints, demonstrating a 90% complete response (CR) rate and a best overall response rate (ORR) of 99%, as assessed by blinded independent central review. All evaluable patients responded to treatment, resulting in 100% local tumor control—one of the highest reported response outcomes in Y-90 therapy. Responses were durable, with 75% lasting beyond six months and a median duration of 295 days, reinforcing the potential of SIR-Spheres Y-90 resin microspheres to deliver sustained tumor responses while preserving liver function.

Importantly, over 95% of patients maintained stable liver function at 12 months, underscoring the ability of personalized dosimetry to achieve aggressive tumor response without compromising hepatic reserve.

These results were presented as a late-breaking oral presentation at the Society of Interventional Radiology (SIR) Annual Meeting in Toronto, Canada.

"These 12-month results demonstrate the consistency of response achievable with personalized dosimetry," said Dr. Armeen Mahvash, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90 study. "The high complete response rates, durability and preservation of liver function observed in this study give physicians increased confidence in using radioembolization as a definitive, liver-directed treatment option."

"These results raise the bar for what physicians should expect from Y-90 therapy," said Matt Schmidt, CEO of Sirtex Medical. "With the overall response rate of 99% and 100% tumor control, DOORwaY90 demonstrates that personalized dosimetry with SIR-Spheres can deliver outcomes that challenge conventional approaches and expand what’s possible in liver-directed therapy for patients with unresectable HCC."

SIR-Spheres Y-90 resin microspheres are the only radioembolization therapy approved by the FDA for the treatment of both metastatic colorectal cancer (mCRC) of the liver and unresectable HCC in the U.S.

For more information about SIR-Spheres and guidance on incorporating personalized dosimetry into clinical practice, please contact Sirtex at [email protected].

About SIR-Spheres
SIR-Spheres Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Common side effects include abdominal pain, nausea and constipation. Consult www.sirtex.com/sir-spheres/risks_adverse-events for a complete listing of side effects, warnings and precautions.

(Press release, Sirtex Medical, APR 13, 2026, View Source [SID1234664334])

On April 13, 2026, IDEAYA Biosciences, Inc. (the "Company") and Servier, an independent international pharmaceutical group governed by a foundation, reported clinical data from the Company’s Phase 2/3 registrational trial, OptimUM-02, evaluating darovasertib in combination with crizotinib (darovasertib combination) in patients with first-line ("1L") HLA-A*A2:01-negative metastatic uveal melanoma ("mUM").

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The darovasertib combination met the trial’s primary endpoint of a statistically significant improvement in median progression-free survival ("PFS") relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review ("BICR"). The secondary endpoints in the study include overall response rate ("ORR") and duration of response ("DOR"). The topline results were from a total of 313 patients enrolled in the Phase 2b/3 portion of the trial as of the cut-off date of January 23, 2026. The PFS analysis was based on a total of 159 events.

OptimUM-02 is a global, randomized Phase 2/3 trial in 1L HLA-A*A2:01-negative MUM evaluating the darovasertib combination arm of 210 patients versus the ICT arm reflective of real-world clinical practice that consists of 103 patients. The ICT arm was composed of 76% (n=78) ipilimumab plus nivolumab (anti-CTLA-4/PD-1) and 24% (n=25) pembrolizumab (anti-PD-1). The primary endpoint is median PFS as assessed by BICR, which will be used to support an initial New Drug Application ("NDA") submission in the United States.

The Company reported that patients treated with the darovasertib combination reduced their risk of disease progression as assessed by BICR by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieved a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm. The Company also reported that ORR by BICR in the darovasertib combination and ICT arm was 37.1% and 5.8% (p-value: <0.0001), respectively. There were 5 complete responses by BICR observed in the darovasertib combination arm, and no complete responses observed in the ICT arm. The median DOR in the darovasertib combination arm was 6.8 months. The overall survival ("OS") data is not mature. However, the Company observed that, in the OptimUM-02 study, there is an early trend in improvement in OS with the darovasertib combination arm versus the ICT arm. The darovasertib combination was generally well-tolerated with a manageable safety profile consistent with prior reported results and known side-effects of each drug. The most common Grade 3+ treatment emergent adverse events included diarrhea, syncope, and hypotension. The treatment related serious adverse events rate in the darovasertib combination was in the single digit percent range.

Based on these data, the Company will target to submit an NDA to the U.S. Food and Drug Administration ("FDA") in the second half of 2026. The Company plans to provide additional details from OptimUM-02 at a major medical conference in 2026.

(Press release, Ideaya Biosciences, APR 13, 2026, View Source [SID1234664318])

On April 13, 2026 Genialis, the therapeutic intelligence company, reported it will present the first results from a new AI-based algorithm designed to distinguish between patients more likely to benefit from treatment with trastuzumab deruxtecan (Enhertu, T-DXd). Built using the Genialis Supermodel, and evaluated on real-world clinical data from Tempus, including a cohort of 90 breast cancer patients with HER2-positive, HER2-low and HER2-ultra-low disease, the model demonstrates statistically significant discriminatory performance that outperforms standard HER2 diagnostics. The full poster will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (April 17–22; San Diego).

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Antibody-drug conjugates (ADCs) are among the fastest-growing drug classes in oncology, yet patient selection still relies on diagnostics that measure target expression without capturing the tumor biology that determines response. For HER2-directed ADCs like Enhertu, that gap spans the full HER2 spectrum: clinical benefit varies substantially across HER2-measured disease status, and IHC (Immunohistochemistry) or FISH (Fluorescence In Situ Hybridization) testing cannot reliably identify who will respond.

Genialis used the Genialis Supermodel, a large molecular foundation model trained on billions of RNA-seq-derived data points, to develop a predictive model for T-DXd response. The Supermodel translates tumor gene expression into hundreds of biomodules, or machine learning-derived representations of biological processes. By incorporating biomodules relevant to ADC mechanisms, including targeting, internalization, and payload activity, the model captures the underlying biology associated with treatment response.

The model was developed and evaluated in a real-world clinical cohort of T-DXd-treated breast cancer patients from the Tempus multimodal database. Using real-world clinical benefit duration (CBD) as the survival endpoint, the model achieved statistically significant predictive discrimination: hazard ratio 2.22 (95 percent CI 1.14–4.35), p = 0.020. Patients predicted as likely to benefit had a median duration of treatment of 345 days, compared to 245 days for those patients unlikely to benefit, a 41 percent difference. No prognostic signal was observed in control cohorts (HR ≈ 1.0), confirming that the model captures treatment-specific benefit rather than general prognosis.

"Better biomarkers for HER2-directed ADCs are urgently needed as current diagnostics were designed to measure receptor expression, not the full biology of drug response," said Mark Uhlik, PhD, Chief Scientific Officer of Genialis. "Enhertu response involves multiple biological processes beyond HER2 expression, including internalization, payload activity, and the tumor’s damage response. These aren’t captured by IHC. The Supermodel is designed to represent those processes using comprehensive RNA data, which helps explain the signal we’re presenting at AACR (Free AACR Whitepaper)."

The model’s strongest predictive features are associated with ADC biology rather than HER2 expression alone, including topoisomerase payload activity, DNA damage response, hypoxia, and tumor stress pathways, illustrating why receptor-level diagnostics cannot capture the full complexity of ADC response.

Improving patient selection remains a major challenge in cancer drug development, especially as ADC pipelines continue to expand. With more than 1,000 ADC programs in clinical development, there is a growing demand for biomarker strategies that can keep pace with the diversity of these therapies. The Genialis Supermodel’s modular architecture independently captures each biological step of ADC mechanism, making it applicable to any antibody-payload combination. Genialis is already applying this framework to multiple ADC programs in collaboration with pharmaceutical and biotech partners.

"HER2 IHC tells you what a tumor expresses. The Supermodel tells you the biology present in a tumor and predicts what will happen when you treat it. That is a fundamentally different kind of information, and it is what drug developers need to make smarter decisions earlier in ADC development," said Rafael Rosengarten, PhD, Chief Executive Officer of Genialis. "This Enhertu predictor is another example of the Supermodel’s broad application across the ADC pipeline, and we are rapidly extending this work with our pharma and biotech partners."

Poster Presentation Details:

Title: "An RNA-Based Survival Model Predicting Real-World Response to Trastuzumab Deruxtecan"
Meeting: AACR (Free AACR Whitepaper) Annual Meeting 2026
Date: April 22, 2026 | 9:00 AM– 12:00 PM
Location: San Diego Convention Center — Poster Section 3, Board 27
Poster Number: 6883
For more information on Genialis and the Supermodel platform, including krasID and Expressions, visit www.genialis.com.

(Press release, Genialis, APR 13, 2026, View Source [SID1234664335])

On April 13, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that the first patient has been dosed in one of three expansion cohorts in the Phase 1 trial evaluating VIR-5500, a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN dual-masked T-cell engager (TCE) for metastatic prostate cancer (NCT05997615). The Phase 1 trial is measuring the safety and efficacy of VIR-5500 monotherapy in late-line mCRPC, and of VIR-5500 in combination with an androgen receptor pathway inhibitor (ARPI) in early-line mCRPC and mHSPC.

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"The initiation of the VIR-5500 expansion cohorts underscores the significant momentum behind this program and the enthusiasm we are seeing across the clinical community," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "We are encouraged by the promising anti-tumor activity shown in the Phase 1 data announced earlier this year and look forward to collaborating with Astellas after closing of the transaction to explore VIR-5500’s potential to make a meaningful difference across the spectrum of metastatic prostate cancer."

The monotherapy expansion cohort in late-line mCRPC is the first to begin enrollment based on the monotherapy dose-escalation data that showed VIR‑5500 has a favorable safety profile and promising anti-tumor activity in mCRPC. These safety and efficacy data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February. Based on these data, the selected dose regimen to be evaluated in this monotherapy expansion cohort is Q3W 800/2000/3500 µg/kg step-up dosing. This expansion cohort will measure safety and efficacy, including Prostate-Specific Antigen (PSA) response rate and Objective Response Rate (ORR) in patients with mCRPC who are refractory following treatment with multiple prior lines of therapy including at least one second-generation ARPI and one taxane regimen in addition to standard-of-care radioligand-based therapy.

"Building on the encouraging Phase 1 dose-escalation monotherapy data, this milestone represents an important step in further evaluating VIR-5500’s best-in-class potential," said Anthony Jarkowski, Primary Focus Lead, Immuno-oncology, Astellas. "We look forward to starting our collaboration with Vir Biotechnology to potentially benefit more people living with prostate cancer, where there remains a significant unmet medical need."

Dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The Company anticipates dosing of first patients in the combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by pivotal Phase 3 trials in 2027.

About Advanced Prostate Cancer

Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.1 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).2 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).3 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.4 There is a critical need for safer, more effective, and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.

About VIR-5500

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is the only dual-masked PSMA-targeting TCE in clinical evaluation.

VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN masking technology. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.

(Press release, Vir Biotechnology, APR 13, 2026, View Source [SID1234664336])

On April 13, 2026 Iterion Therapeutics reported that two abstracts featuring its first-in-class TBL1 inhibitor, tegavivint, will be presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Each will highlight the company’s approach to targeting the Wnt/β-catenin pathway, one of the most frequently dysregulated signaling programs in cancer.

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Despite its role in an estimated 25–30% of solid tumors, the Wnt/β-catenin pathway has historically proven difficult to target therapeutically. Earlier efforts focused on inhibiting upstream components of the pathway and were often limited by bone and gastrointestinal toxicities.

Tegavivint takes a differentiated approach by targeting TBL1, a transcriptional regulator required for β-catenin–mediated gene expression. By disrupting the TBL1–β-catenin transcriptional complex, tegavivint promotes degradation of nuclear β-catenin, inhibits oncogenic transcriptional programs driven by Wnt signaling, and has demonstrated potent anti-tumor activity in preclinical models and clinical studies.

"These data further support our strategy of targeting TBL1 as a novel approach to treating Wnt-driven cancers," said Rahul Aras, Ph.D., President and Chief Executive Officer of Iterion Therapeutics. "As clinical momentum builds in hepatocellular carcinoma and our program expands into colorectal cancer and pediatric osteosarcoma, we see the potential for tegavivint to play an important role across multiple cancers where Wnt signaling drives disease."

Iterion recently completed a Phase 1 study of tegavivint in patients with advanced hepatocellular carcinoma (HCC), where the therapy demonstrated encouraging clinical responses and durable disease control in heavily pre-treated patients, along with a favorable tolerability profile. Detailed results from the study are expected to be presented at a scientific conference later this year as the company prepares to advance tegavivint into Phase 2 development in HCC.

The two presentations highlight both the mechanistic basis of tegavivint’s activity and its emerging potential across multiple Wnt-driven cancers.

Building on a recently initiated Phase 1 clinical study in colorectal cancer, one presentation describes the activity of tegavivint in Wnt-driven colorectal cancer models, demonstrating potent anti-tumor activity in preclinical models characterized by activation of the Wnt/β-catenin pathway. These findings support the continued clinical development of tegavivint and exploration of combination strategies in colorectal and other cancers.

A second presentation further characterizes the mechanism of action of tegavivint and the characterization of TBL1 as a druggable therapeutic target within the Wnt/β-catenin pathway. The work highlights how targeting TBL1 can selectively disrupt β-catenin–dependent transcriptional activity and supports the broader potential of this approach across Wnt-driven cancers.

AACR Presentation Details

Poster 1: Tegavivint, a first-in-class TBL1 inhibitor demonstrates potent activity in WNT-driven colorectal cancers
Presenter: Stephen Horrigan, Ph.D., Chief Scientific Officer
Session Title: CL07.02 – Molecular Targeted Therapy
Abstract Number: 3900/6
Date / Time: Monday April 20th, 2026, 2:00-5:00pm
Location: Section 47
Poster 2: Tegavivint directly targets TBL1 to inhibit β-catenin nuclear oncogenic activity
Presenter: Aundrietta Duncan, Ph.D., Sr. Director of Translational Research and Non-Clinical Development
Session Title: ET05.01 – Mechanisms of Anticancer Drug Action
Abstract Number: 5669/15
Date / Time: Tuesday April 21st, 2:00-5:00pm
Location: Section 12

(Press release, Iterion Therapeutics, APR 13, 2026, View Source [SID1234664320])