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 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported its participation at the 25th Annual Needham Virtual Healthcare Conference, being held April 13-16, 2026. Company management will participate in virtual one-on-one meetings with investors during the conference.

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(Press release, Sapience Therapeutics, APR 13, 2026, View Source [SID1234664333])

On April 13, 2026 BioOra Limited and Cincinnati Children’s reported a strategic partnership to advance Atla-cel, (atlacabtagene autoleucel, pINN List 134), a third-generation CD19-directed CAR-T cell therapy, into clinical development for children and adolescents with relapsed or refractory B-cell acute lymphoblastic leukaemia (B-ALL).

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A differentiated safety profile — and what it means for children

Despite significant advances in frontline therapy, children with relapsed or refractory B-ALL face poor long-term outcomes and limited treatment options. First-generation approved CAR-T therapies have demonstrated meaningful efficacy. However, cytokine release syndrome (CRS) and, in particular, immune effector cell-associated neurotoxicity syndrome (ICANS), remain barriers to broader adoption, especially in paediatric patients, where neurotoxicity carries heightened developmental risks and typically requires intensive inpatient monitoring.

Atla-cel is a third-generation CD19-directed CAR-T therapy incorporating design advances intended to enhance anti-tumour activity and improve the tolerability profile compared with earlier-generation approaches. Results from the Phase 1 ENABLE-1 study in adults with relapsed or refractory lymphoma, presented at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, demonstrated promising complete response rates alongside a safety profile notable for low rates of serious CRS and, critically, markedly reduced ICANS. These safety signals position Atla-cel as a compelling candidate for paediatric investigation.

In children, ICANS is not a side effect to be managed, it is an unacceptable risk. The developing brain is uniquely vulnerable to immune-mediated neurotoxicity, and this has kept CAR-T therapy from reaching many of the patients who need it most. The markedly low ICANS rates observed in adult studies provide the strongest rationale yet for paediatric evaluation and raise the prospect of outpatient delivery that would free children and families from the prolonged inpatient stays that currently approved therapies require.

The partnership with Cincinnati Children’s, one of the world’s leading paediatric academic medical centres with deep expertise in haematology, oncology, and cellular therapies, leverages clinical data from the ENABLE trial programme, conducted in collaboration between BioOra and the Malaghan Institute of Medical Research in New Zealand. Atla-cel incorporates design advances aimed at enhancing anti-tumour activity while improving tolerability compared with earlier-generation CAR-T therapies.

As part of the collaboration, Steve Davis, MD, President and Chief Executive Officer of Cincinnati Children’s, joins the BioOra Board of Directors.

Clinical programme: trial sites and leadership

The proposed paediatric B-ALL clinical programme would enrol patients across the United States, New Zealand, and potentially Australia, with trial management from Cincinnati Children’s.

The trial will be led by Stella M. Davies, MBBS, PhD, MRCP, Institute Co-Executive Director of the Cancer and Blood Diseases Institute and Director of the Division of Bone Marrow Transplantation and Immune Deficiency at Cincinnati Children’s, ranked the #1 cancer care provider in the United States by US News and World Report. Dr. Davies is a recognised leader in paediatric haematology-oncology and haematopoietic cell transplantation and currently serves as President-Elect of the American Society for Transplantation and Cellular Therapy.

Leadership perspectives

Laurence Cooper, MD, PhD, paediatric oncologist and Board Member of BioOra, said: "Children with relapsed B-ALL deserve effective, safer, and more accessible therapies. The ENABLE programme has given us confidence in Atla-cel’s adult safety profile; markedly reduced neurotoxicity is not a minor footnote in paediatric oncology, it is central to whether a therapy can safely be used in children. That is why this paediatric programme matters."

Stella M. Davies, MBBS, PhD, MRCP, Institute Co-Executive Director, Cancer and Blood Diseases Institute, Cincinnati Children’s, and Principal Investigator, said: "Relapsed B-ALL remains one of the toughest problems in childhood cancer. The low neurotoxicity signals from the ENABLE programme make Atla-cel a compelling candidate for paediatric investigation, and if that profile holds in children, it could mean bringing life changing CAR-T therapy to more kids."

John Robson, Chief Executive Officer of BioOra, said: "This collaboration reflects our conviction that next-generation CAR-T design, disciplined clinical execution, and automated manufacturing can together transform outcomes for children with ALL. Cincinnati Children’s brings the scientific depth, paediatric expertise, and global credibility this programme demands, and we are proud to partner with them."

Steve Davis, MD, President and Chief Executive Officer of Cincinnati Children’s, said: "Cincinnati Children’s is committed to delivering the safest and most advanced therapies to children with cancer. Atla-cel’s emerging safety profile, combined with BioOra’s manufacturing expertise and our shared clinical vision, creates a strong foundation to pursue a genuinely differentiated treatment option for children with relapsed B-ALL in the United States and globally."

(Press release, BioOra, APR 13, 2026, View Source [SID1234664332])

On April 13, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that results from both the ovarian cancer cohort and the cervical cancer cohort of Phase II study SKB264-II-06/MK-2870-002 of the TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱), in combination with MSD’s[1] anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA[2]), were selected for oral presentation at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting in San Juan, Puerto Rico. The data were presented by Professor Xiaohua Wu of Fudan University Shanghai Cancer Center.

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Ovarian cancer

This presentation reported, for the first time, important data on sac-TMT as maintenance treatment in breast cancer susceptibility gene (BRCA) wild-type, second-line platinum-sensitive recurrent ovarian cancer. Among the 40 patients enrolled in the ovarian cancer cohort, 27 received sac-TMT (4 mg/kg, every other week (Q2W)) in combination with pembrolizumab, and 13 received sac-TMT (5 mg/kg, Q2W) in combination with pembrolizumab. Among the enrolled patients, 70% had prior bevacizumab therapy, and 58% had prior PARP inhibitor therapy. The median follow-up was 22.2 months (data cutoff date: November 17, 2025).

The data showed that median progression-free survival (PFS) in the overall population was 20.9 months; median overall survival (OS) was not reached; and the 12-month OS rate was 92%. Additionally, the adverse events of sac-TMT in combination with pembrolizumab were manageable. The most common treatment-related adverse events (TRAEs) were anemia, stomatitis, and decreased neutrophil count. No deaths or discontinuations due to sac-TMT-related TRAEs was reported.

The study results showed that sac-TMT in combination with pembrolizumab as maintenance therapy for platinum-sensitive recurrent ovarian cancer demonstrated positive efficacy signals and a favorable safety profile, providing important evidence for further clinical exploration of this combination regimen in the ovarian cancer population.

Cervical cancer

A total of 68 patients with previously treated second-line or third-line recurrent or metastatic cervical cancer were enrolled in the cervical cancer cohort to receive sac-TMT at doses of 3 mg/kg, 4 mg/kg, or 5 mg/kg Q2W in combination with pembrolizumab. Among the enrolled patients, 57% had prior bevacizumab therapy, and 51% had prior immunotherapy. The median follow-up was 24.7 months (data cutoff date: November 17, 2025).

The data showed that after treatment with sac-TMT in combination with pembrolizumab, the objective response rate (ORR) in the total population was 51% and 54% in IO-pretreated population. The median PFS was 7.3 months and the median OS reached 18.9 months in the total population. Furthermore, the safety profile of sac-TMT in combination with pembrolizumab was manageable, with no new safety signals identified and no deaths due to TRAEs.

The study results demonstrated promising and durable antitumor activity with a manageable safety profile in patients with pre-treated second-line or third-line recurrent or metastatic cervical cancer receiving sac-TMT in combination with pembrolizumab, providing robust data to support further clinical development.

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications listed above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, APR 13, 2026, View Source [SID1234664331])

On April 13, 2026 Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is October 10, 2026.

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Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The FDA is also reviewing the BLA under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

The BLA is based on results from the IDeate-Lung01 Phase 2 trial, with support from the IDeate-PanTumor01 Phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 were presented at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25) and published in the Journal of Clinical Oncology. Ifinatamab deruxtecan also was previously granted Breakthrough Therapy Designation by the FDA in August 2025 for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.

"The FDA’s granting of Priority Review for ifinatamab deruxtecan marks a significant milestone in our effort to provide new and innovative treatment options for patients with extensive-stage small cell lung cancer," said John Tsai, MD, global head, R&D, Daiichi Sankyo. "We look forward to continuing to work with the FDA to bring this potential first-in-class B7-H3 directed DXd antibody drug conjugate to patients as quickly as possible."

"Small cell lung cancer remains one of the toughest cancers to treat, with few options if the disease progresses after standard of care treatments," said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "The FDA’s acceptance of the BLA reinforces the important role that ifinatamab deruxtecan could play in helping to address the needs of patients with extensive-stage small cell lung cancer."

About IDeate-Lung01

IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part Phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with ES-SCLC who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible to participate.

In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan (8 or 12 mg/kg) given intravenously once every three weeks. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan (12 mg/kg) intravenously at the same dosing interval.

The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), time to response (TTR), overall survival (OS), pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis.

IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About IDeate-PanTumor01

IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label Phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists.

The Phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The Phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistant prostate cancer or esophageal squamous cell carcinoma.

The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating ORR, DOR, DCR, PFS, OS and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints also will be assessed.

IDeate-PanTumor01 will enroll approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov.

About small cell lung cancer

Approximately 250,000 patients are diagnosed with small cell lung cancer (SCLC) each year globally. There were approximately 27,000 new cases of SCLC in the U.S. in 2025, accounting for about 12% of all lung cancer cases. SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches.

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. There are currently no B7-H3 directed medicines approved for the treatment of cancer.

About ifinatamab deruxtecan

Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Ifinatamab deruxtecan was granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.

Ifinatamab deruxtecan has been granted Orphan Drug Designation (ODD) by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. Ifinatamab deruxtecan also was granted ODD for the treatment of esophageal cancer by the FDA.

About the ifinatamab deruxtecan clinical development program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other cancer medicines across multiple cancers. The program is currently comprised of three Phase 3 trials in advanced/metastatic disease, including SCLC (IDeate-Lung02), castration-resistant prostate cancer (IDeate-Prostate01) and esophageal squamous cell carcinoma (IDeate-Esophageal01).

(Press release, Merck & Co, APR 13, 2026, View Source [SID1234664330])