Tecentriq Filed for Additional Indication as Maintenance Therapy Following Definitive Chemoradiotherapy in Locally Advanced Esophageal Cancer

On June 12, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for an additional indication as maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer.

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"There is no established standard treatment for maintenance therapy following definitive chemoradiotherapy for locally advanced esophageal cancer. In the SKYSCRAPER-07 study, Tecentriq monotherapy indicated a trend toward improvement in overall survival and progression-free survival compared with placebo. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients as a new therapeutic option as soon as possible," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the global Phase III clinical study (SKYSCRAPER-07/ YO42137)1 in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study is a randomized, double-blind, multicenter trial comparing the efficacy and safety of maintenance therapy with Tecentriq in combination with tiragolumab (development discontinued) or Tecentriq monotherapy versus placebo. Based on the results from the first 2 and second interim analyses, it was confirmed that the Tecentriq monotherapy arm continued to show clinical benefit in the primary endpoint of overall survival (OS) and the secondary endpoint of investigator-assessed progression-free survival (PFS). The results of the second interim analysis are planned to be presented at an upcoming medical congress. The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

About the SKYSCRAPER-07 (YO42137) study1
SKYSCRAPER-07 is a global Phase III randomized, double-blind, multicenter study in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study evaluated the efficacy and safety of Tecentriq plus tiragolumab or Tecentriq monotherapy compared with placebo. Development of the Tecentriq plus tiragolumab combination was discontinued as no clinical benefit was observed in the primary PFS analysis and the first interim OS analysis (cutoff: February 18, 2025)2.

About maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer3
Esophageal cancer has an incidence rate in Japan (2021) of 34.7 per 100,000 population for men and 7.7 per 100,000 population for women. The number of deaths from esophageal cancer in 2024 was 10,638, and the 5-year relative survival rate (2009–2011) was 41.5%.
In Japan, squamous cell carcinoma is the most common histologic type. In unresectable, locally advanced esophageal squamous cell carcinoma, there is no clearly established standard treatment for patients without disease progression after definitive chemoradiotherapy, and new treatment options are needed.

About Tecentriq4
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JUN 11, 2026, View Source;category= [SID1234666579])

BlossomHill Therapeutics Presents Initial Clinical Data from Dose Escalation in Ongoing Phase 1/1b Trial of Novel Macrocyclic CLK Inhibitor, BH-30236, in Patients with R/R AML or HR-MDS at EHA 2026

On June 11, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported initial clinical data from its ongoing first-in-human Phase 1/1b trial of BH-30236 in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndrome (HR-MDS) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden. BH-30236 is an intentionally designed novel, orally bioavailable, macrocyclic CDC-like kinase (CLK) inhibitor that modulates aberrant alternative mRNA splicing, a defining feature implicated in cancer progression and therapeutic resistance across both hematologic malignancies and solid tumors.

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"The preliminary anti-leukemic activity observed with BH-30236 in R/R AML and HR-MDS, both as a monotherapy and in combination with venetoclax, is very encouraging," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "In addition to the reassuring tolerability profile, we have seen provocative responses in patients after progression on prior venetoclax-based therapy, a population with few treatment options. In the ongoing study of BH-30236, we will further characterize the effect of this novel mechanism in myeloid malignancies, both as a monotherapy and in synergy with venetoclax to maximize the potential of this promising program."

"We intentionally designed BH-30236 to target CLK, which is upstream of multiple resistance pathways, not by addressing one resistance mechanism after it develops, but by suppressing the splicing machinery that enables resistance to begin," said Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "We believe these data further validate our approach of leveraging a deep understanding of disease and protein dynamics and applying our structure-based rational drug design expertise to identify specific structural liabilities that limit existing therapies or approaches and design novel chemical scaffolds to directly address these limitations."

Presentation Highlights:

As of the data cutoff date of April 10, 2026, 30 patients received BH-30236 monotherapy at doses ranging from 5 to 120 mg on a continuous daily administration schedule (QD), and 18 patients received BH-30236 at doses ranging from 20 to 90 mg QD in combination with venetoclax
BH-30236 was generally well tolerated as both a monotherapy and in combination with venetoclax, with most treatment-related adverse events being low-grade and manageable, with one dose limiting toxicity of Grade 3 diarrhea at the 120 mg QD monotherapy dose level
Dose escalation showed predictable pharmacokinetics without drug accumulation, and no significant drug-drug interactions were observed with venetoclax
With efficacy follow-up through May 20, 2026, preliminary anti-leukemic activity was observed in patients with R/R AML and HR-MDS when treated with BH-30236 as a monotherapy or in combination with venetoclax, including in patients previously relapsed or refractory to venetoclax-based therapy:
In the monotherapy cohort, 28.6% (n=6) of evaluable patients achieved at least a 50% reduction in bone marrow blast counts, including one HR-MDS patient treated at 60 mg with ongoing blast count reduction with treatment ongoing for more than a year
In the combination cohort, 87% (n=13) of patients had prior venetoclax exposure and 53% (n=8) of evaluable patients experienced at least a 50% blast reduction, including one patient refractory to all prior therapy including venetoclax, who achieved a minimal residual disease (MRD)-negative complete remission

About R/R AML and HR-MDS
AML is the most common acute leukemia in adults, with approximately 21,000 new diagnoses annually in the United States, with as many as 75% of those being patients resistant to or relapsing on first-line venetoclax therapy. Approximately 14,000 patients are diagnosed with HR-MDS annually in the United States. There is no currently approved targeted therapy for the venetoclax-resistant and refractory segment of AML patients without targetable genetic alterations. Patients with HR-MDS closely mirror AML in clinical course, frontline treatment, and unmet need in the relapsed and refractory setting.

About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 is was intentionally designed to potently inhibit CLK, leading to modulation of aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives relapsed or refractory (R/R) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine.

BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BH-30236 for the treatment of AML.

(Press release, BlossomHill Therapeutics, JUN 11, 2026, View Source [SID1234666595])

TriSalus Life Sciences to Host Virtual KOL Event on June 24 Featuring New Real-World Evidence for Pressure-Enabled Drug Delivery™ in Liver Cancer

On June 10, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI), an oncology company integrating novel delivery technology with standard-of-care therapies and an investigational immunotherapeutic to transform outcomes for patients with solid tumors, reported it will host a virtual key opinion leader (KOL) event on Wednesday, June 24, 2026 at 8:00 AM ET. The event will feature the findings of a newly published real-world outcomes study demonstrating that Pressure-Enabled Drug Delivery (PEDD) delivered a 48% improvement in drug delivery to target tumors while reducing complications associated with off-target administration when compared with conventional embolization approaches — results with meaningful implications for the estimated 900,000 patients diagnosed annually worldwide with primary liver tumors or liver metastases.

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Alexander S. Misono, MD, MBA, RPVI, Chief of Interventional Radiology at Hoag Hospital (Newport Beach, CA), will join TriSalus management to discuss the current treatment landscape for hepatocellular carcinoma (HCC) and liver metastases, how the new real-world evidence shapes patient selection and treatment strategy, and share clinical experience and case examples using the TriNav Infusion System. A live Q&A session will follow the formal presentations, providing direct engagement with management and Dr. Misono.

Event: Virtual KOL Webinar

Date: Wednesday, June 24, 2026

Time: 8:00 AM ET

Speaker: Alexander S. Misono, MD, MBA, RPVI — Chief of Interventional Radiology, Hoag Hospital

Register: View Source

"The publication of this real-world evidence marks an important milestone in demonstrating the clinical and economic value of PEDD technology for patients undergoing liver embolization. We look forward to a rich discussion with Dr. Misono on how these findings can help interventional oncologists optimize treatment decisions and improve outcomes for their patients."

— Mary Szela, President & CEO, TriSalus Life Sciences

The TriNav Infusion System is one of three FDA-cleared devices in the TriSalus platform that utilize the PEDD approach to deliver therapeutics directly to liver and pancreatic tumors. The technology is designed to modulate pressure and flow to maximize drug delivery to the tumor while reducing undesired delivery to healthy tissue.

(Press release, TriSalus Life Sciences, JUN 10, 2026, View Source [SID1234666548])

Orionis Biosciences Announces Strategic Collaboration with Novartis to Discover and Develop Molecular Glue Medicines

On June 10, 2026 Orionis Biosciences, a privately held, clinical-stage life sciences company pioneering proximity-induced therapeutic modalities, reported a multi-year collaboration with Novartis to discover and design molecular glue drugs for challenging therapeutic targets across multiple disease areas. The collaboration expands the existing relationship between the companies and reflects a shared commitment to unlock the full value of induced proximity approaches in drug development.

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Under the terms of the agreement, Novartis and Orionis will use Orionis’s Allo-Glue platform, together with its AI-driven discovery engine, to accelerate target and ligase profiling and molecular glue optimization. These integrated capabilities enable the systematic discovery of small molecule glues that modulate therapeutic targets through induced proximity mechanisms. Orionis will receive an upfront payment of USD 40 million and is eligible to receive research, development, and commercial milestone payments of up to USD 1.4 billion, in addition to tiered royalties on net sales of collaboration products.

"We are proud to renew and expand our collaboration with Novartis," said Niko Kley, Chief Executive Officer of Orionis Biosciences. "Having such a partner continue to engage deeply with us is a strong validation of the value of our molecular glue platform and the progress we have achieved toward rational and scalable discovery of this emerging drug class."

"Our recent advances in AI and robotic automation have accelerated all aspects of molecular glue discovery, from systematic prioritization of productive target–ligase pairs to glue candidate discovery and optimization," said Riccardo Sabatini, Chief Data Scientist at Orionis Biosciences. "This is exactly the kind of platform maturity that makes collaborations like this possible."

"We are excited to deepen our collaboration with Orionis and to explore the full potential of molecular glue modalities across multiple therapeutic areas," said John Tallarico, Head of Discovery Sciences at Novartis. "The Orionis platform offers an opportunity to rapidly uncover and design molecular glue mechanisms, enabling us to expand the horizon of targetable biology for future therapies."

(Press release, Orionis Biosciences, JUN 10, 2026, View Source [SID1234666549])

PhoreMost Announces Lead Oncology Programme and Appoints Chief Medical Officer to Support Clinical Entry

On June 10, 2026 PhoreMost Limited ("PhoreMost"), a biotech company focused on turning scientific breakthroughs into life-changing cancer drugs, reported its lead programme, PMC-001, a next-generation, small molecule microtubule targeting agent (MTA) for primary and secondary brain cancers. The milestone marks the Company’s progress towards first-in-human clinical trials, with a pipeline of differentiated and first-in-class assets in oncology.

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PMC-001 is a highly differentiated, orally bioavailable MTA, positioned to treat primary brain cancers, including glioblastoma, and secondary brain cancers frequently metastasising from advanced lung, breast and other tumour types, with strong potential for further indication expansion. While existing MTAs, such as taxanes, are broadly effective against multiple cancer types, they exhibit a lack of oral bioavailability and blood-brain barrier penetration. Primary and secondary brain cancers represent areas of significant unmet clinical need and high prevalence, creating a multibillion-dollar market opportunity.

PMC-001 is a small molecule with favourable drug-like properties possessing oral activity, CNS-penetration and ease of scaling. Preclinical safety and toxicology studies have demonstrated strong anti-tumour efficacy with excellent tolerability across diverse oncology-focussed models with an attractive dosing regimen. CMC has now been completed and PhoreMost is preparing imminent regulatory filings for trial initiation. The programme originates from the Company’s longstanding collaboration with Sentinel Oncology, with PhoreMost now taking the candidate forward.

Gabriel Fox, MB BChir, joins PhoreMost as Consulting Chief Medical Officer to lead the clinical development of PMC-001. Dr Fox completed his medical training at the University of Cambridge and brings 30 years of industry experience from global pharmaceutical companies such as Roche and Gilead Sciences, spanning the entire drug development process.

Dr Neil Torbett, CEO of PhoreMost, said: "PMC-001 shows striking tumour growth inhibition and holds great promise in delivering clinical benefit to patient groups that represent the highest areas of unmet need – announcing the programme is a fantastic milestone. With Gabriel’s extensive experience, we are excited to build on the impressive preclinical proof points and progress towards first-in-human trials, to deliver on our promise of unlocking the next generation of medicines."

Dr Gabriel Fox, Consulting CMO of PhoreMost, added: "I am thrilled to be joining PhoreMost as it reaches this significant milestone and approaches clinical stage. PMC-001 has performed exceptionally well in preclinical studies, the nature of the asset and mechanism of action is particularly impressive and will deliver clinical efficacy inflections rapidly. PMC-001 is well positioned to make a real difference. Having seen first-hand the patient need for new treatment options for both primary brain cancers and cancers with brain metastases, I am excited to be a part of the team moving it into the clinic."

(Press release, PhoreMost, JUN 10, 2026, View Source [SID1234666550])