On May 18, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), a clinical-stage biotechnology company developing immunotherapies for cancer patients, reported that members of its executive team will participate in one-on-one investor meetings at the following conference:

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Jefferies Global Healthcare Conference 2026

Dates: June 2–4, 2026
Location: New York, United States

(Press release, Innate Pharma, MAY 18, 2026, View Source [SID1234665840])

On May 18, 2026 AstraZeneca and Roche Diagnostics Asia Pacific reported a three-year Memorandum of Understanding to help advance digital pathology capabilities and elevate cancer care across nine Asia markets, a first in the region. This landmark collaboration aims to accelerate the adoption of AI-powered digital and computational pathology through educational and training initiatives and improve biomarker testing in breast and lung cancer.

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Globally, nearly half of all breast cancer cases[1] and over 60% of new lung cancer diagnoses[2] occur in Asia. In breast cancer, almost half of Asian women present lower levels of HER2,[3] while TROP2 is present in 82–90% of non-small cell lung cancer.[4] Precise biomarker testing is hence key to guiding treatment decisions, and AI-enabled TROP2 assessment helps identify patients who are more likely to respond to antibody drug conjugate therapies.

This collaboration addresses the critical knowledge and adoption gap in AI-assisted pathology across Asia. Only 17% of clinicians consider themselves very aware of advanced pathology technologies, and usage of computational pathology-based tests in clinical settings is low.[5] For example, in the Philippines, 60% of medical oncologists report that unavailability of biomarker testing has hindered their practice.[6]

"Building resilient health systems is fundamental to our mission of transforming cancer care," said Arun Krishna, Area Vice President, Asia, AstraZeneca. "This collaboration aims to address existing diagnostic gaps across the region. By combining efforts with Roche Diagnostics to advance education and adoption of AI-powered pathology, we can support the integration of precision diagnostics into the patient journey, helping to match more patients to the right treatment at the right time."

AI-assisted pathology helps standardise diagnostic processes, reducing subjectivity, and improving accuracy. Studies show that AI-assisted workflows can[7]:

Improve diagnostic accuracy by up to 5%, reducing reading time per case by 36%.
Increase interpretation concordance by up to 15% by mitigating human fatigue and subjective bias.
Expand access to targeted therapies by reclassifying 24% of cases previously labelled as HER2-negative to HER2-low category.
Enable more precise patient identification through the first AI-powered companion diagnostic for TROP2.[8]
When patients are matched to the right therapies, clinical benefits could include improved response rates, extended progression-free survival,[9] and optimised healthcare resources.

"At Roche Diagnostics, we believe that timely and accurate diagnosis is the foundation of effective cancer care. Across Asia Pacific, gaps in access to advanced diagnostics continue to impact patient outcomes," said Lance Little, Head of Region, Roche Diagnostics Asia Pacific. "Through this collaboration, we are focused on strengthening diagnostic capabilities and accelerating the adoption of digital pathology across healthcare systems. This is key to enabling more consistent and reliable diagnosis, raising the standard of care for patients with lung and breast cancer."

Across Singapore, Taiwan, Korea, Thailand, Malaysia, India, Indonesia, Vietnam, and the Philippines, the collaboration will activate educational and training initiatives that address local healthcare system needs and accelerate the integration of AI-assisted computational pathology into diagnostic workflows.

(Press release, AstraZeneca, MAY 18, 2026, View Source [SID1234665839])

On May 18, 2026 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported the data from its first-in-human Phase 1 Dose Escalation study evaluating BTX-9341, a novel CDK4/6 bifunctional degrader, as monotherapy and in combination with fulvestrant in participants with advanced/metastatic HR+/HER2- breast cancer who received prior CDK4/6 inhibitor therapy. The Phase 1 Dose Expansion portion of the study is currently ongoing.

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"BTX-9341 has a highly favorable safety profile, with no clear evidence of key class related toxicities of other CDK4/6 inhibitors including gastrointestinal toxicities (diarrhea, nausea, vomiting), hepatotoxicity and prolongation of the QTc interval," said Dr. Rachel M Layman, MD (Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center). "The drug shows encouraging clinical activity in a heavily pretreated patient population in the post-CDK4/6 inhibitor setting and shows compelling evidence of the importance of targeting CDK2/4/6 to address multiple resistance pathways."

Data from the Phase 1 Dose Escalation study demonstrate evidence of clinical activity, including prolonged partial response and stable disease in a heavily pretreated patient population. Pharmacokinetic analyses showed BTX-9341 exposures consistent with target engagement concentrations. Importantly, BTX-9341 was well tolerated, with participants on treatment for over 12 cycles (48 weeks), including on monotherapy and in combination with fulvestrant. Adverse events were mild to moderate and easily manageable.

Key Highlights from Dose Escalation Portion of the Phase 1 Study

Favorable safety and tolerability profile with no serious adverse events or treatment discontinuations due to adverse events in all participants (N=28). Hematologic adverse events were transient and reversible. There were no ≥ Grade 3 non-hematologic events.
Approximate dose-proportional pharmacokinetics supporting once-daily dosing.
Clinical activity was observed in a heavily pretreated patient population post-CDK4/6 inhibitors with up to 6 prior lines of therapy in the metastatic setting; approximately 40% and 36% of participants had received chemotherapy and PI3K/AKT/mTOR or other targeted therapies, respectively. Clinical Benefit Rates1 (CBRs) of 41.7% and 80% were observed in treatment-evaluable participants2 (n=24), and participants representative of the dose expansion criteria (n=10), respectively.
Target engagement consistent with CDK4/6 degradation mechanism based on a significant reduction in serum Thymidine Kinase activity, and reductions in the levels of CDK4, CDK6, and CDK2 in peripheral blood mononuclear cells (PBMCs). This is consistent with BTX-9341’s unique ability to address multiple convergent resistance mechanisms to CDK4/6 inhibitor therapies by degrading CDK4/6 and inhibiting downstream transcription of CDK2.
The study is still ongoing with multiple participants remaining on treatment for 12 to >18 cycles. The data are as of May 6, 2026.
"These encouraging clinical results mark an important milestone for our Phase 1 study evaluating BTX-9341, a first-in-class CDK4/6 bifunctional degrader," said Dr. Leah Fung, CEO of Biotheryx. "BTX-9341 has demonstrated a promising safety and tolerability profile, along with early signs of clinical activity in participants whose disease progressed following prior CDK4/6 inhibitor therapy. Given that CDK6 upregulation and Cyclin E amplification are established mechanisms of resistance to CDK4/6 inhibitors, these findings highlight the importance of degrading CDK4/6 and inhibiting downstream transcription of CDK2 to address convergent resistance mechanisms and may redefine the post-CDK4/6 inhibitor setting in advanced/metastatic HR+/HER2- breast cancer."

Advancing to Dose Expansion

Based on these findings, the company is continuing with its Phase 1 Dose Expansion portion of the trial. The expansion cohorts have begun enrolling participants and will further evaluate the efficacy and safety of BTX-9341 in combination with fulvestrant and will build on the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BTX-9341 established in the Dose Escalation phase. The trial is being conducted at multiple sites in the United States and is expected to enroll up to 78 participants across two treatment arms based on the recommended dose identified in the earlier Dose Escalation phase. The primary endpoint of this study is the Overall Response Rate (ORR), with key secondary endpoints including the measurement of investigator-assessed Clinical Benefit Rate (CBR) and Progression Free Survival (PFS).

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated enhanced activity compared with CDK4-only and CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of CDK2 transcription, cell cycle arrest, and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4-only and CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that can limit the impact of inhibitors in second line HR+/HER2- metastatic breast cancer.

(Press release, BioTheryX, MAY 18, 2026, View Source;breast-cancer-302774140.html [SID1234665838])

On May 18, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present new data across its oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2 in Chicago, reinforcing Astellas’ sustained commitment to improving outcomes for people living with cancer. The data will provide further insight into the durable efficacy of established treatment approaches, their use in clinical practice, and ongoing areas of research and development.

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Urothelial carcinoma
In urothelial cancer, a key highlight will be a 3.5-year follow-up oral presentation from the Phase 3 EV-302 study (also known as KEYNOTE-A39), evaluating enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic disease. These data provide additional insight into the durability of outcomes with this treatment approach in advanced disease, an important consideration in clinical management.

Additional data from multiple studies exploring the use of this combination in earlier settings will be presented during the congress. Together, these findings contribute to a broader understanding of how this treatment approach may be applied across advanced disease settings, as well as across patient subgroups.

Prostate cancer
In advanced prostate cancer, additional analyses from established clinical programs in non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR) and hormone- (or castration-) sensitive prostate cancer (mHSPC or mCSPC), including EMBARK and ARCHES, will provide further insight into treatment outcomes in patients with varying clinical characteristics, supporting clinical decision-making in practice.

Women’s health
For the first time at ASCO (Free ASCO Whitepaper), Astellas will present an update on HIGHLIGHT 1, a trial-in-progress investigating the safety and efficacy of fezolinetant for the treatment of moderate to severe vasomotor symptoms in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not been established in this patient population. Fezolinetant is currently approved by the U.S. Food and Drug Administration for the treatment of moderate to severe vasomotor symptoms due to menopause.

Astellas Presentations at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab vedotin

Presentation Title

Lead Author

Presentation Details

Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or
metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study

T. Powles

Type: Oral Presentation

Abstract Number: 4507

Date: May 29, 2026, 2:45 PM-5:45 PM CDT

Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in
participants with muscle-invasive bladder cancer who are cisplatin ineligible: Phase 3 KEYNOTE-905 study

P. O’Donnell

Type: Oral Presentation

Abstract Number: 4510

Date: May 30, 2026, 8:00 AM-9:30 AM CDT

Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants with cisplatin-ineligible
muscle-invasive bladder cancer: An analysis of clinically relevant subgroups in KEYNOTE-905

N. Adra

Type: Poster Presentation

Abstract Number: 4613

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Exploratory subgroup outcomes in the phase 3 KEYNOTE-B15 study of neoadjuvant-adjuvant enfortumab
vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer eligible for cisplatin

C. Hoimes

Type: Poster Presentation

Abstract Number: 4614

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Enzalutamide

Presentation Title

Lead Author

Presentation Details

Predictors of treatment duration in patients with metastatic hormone-sensitive prostate cancer treated with
enzalutamide: a post hoc analysis of ARCHES

A. Armstrong

Type: Poster Presentation

Abstract Number: 5093

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Efficacy and safety of enzalutamide in patients with metastatic hormone-sensitive prostate cancer and
cardiometabolic comorbidities and/or related concomitant medications: ARCHES post hoc

A. Stenzl

Type: Poster Presentation

Abstract Number: 5092

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

EMBARK: Testosterone recovery to >250 ng/dL following treatment suspension

S. Freedland

Type: Poster Presentation

Abstract Number: 5088

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Outcomes with androgen-deprivation therapy (ADT) plus androgen receptor pathway inhibitors (ARPIs) in
veterans with de novo metastatic castration-sensitive prostate cancer (mCSPC) who were elderly, frail,
or had high comorbidity: a subgroup analysis of enzalutamide and high-volume disease

M. Schoen

Type: Poster Presentation

Abstract Number: 5094

Date: May 31, 2026, 9:00 AM-12:00 PM CDT

Fezolinetant

Presentation Title

Lead Author

Presentation Details

HIGHLIGHT 1: A randomized, placebo-controlled, double-blind, phase 3 clinical study to investigate the
efficacy and safety of fezolinetant for treatment of moderate to severe vasomotor symptoms (hot flashes)
in women with stage 0 to 3 hormone receptor–positive breast cancer who are receiving adjuvant
endocrine therapy

C. Bouchard

Type: Poster Presentation

Abstract Number: TPS642

Date: June 1, 2026, 1:30 PM-4:30 PM CDT

Pipeline

Presentation Title

Lead Author

Presentation Details

Trial in progress: ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory
antibody-drug conjugate with dual payloads, in patients with locally advanced unresectable or metastatic
solid tumors: A phase 1b/2 study.

G. Sonpavde

Type: Poster Presentation

Abstract Number: TPS2665

Date: May 30, 2026, 1:30 PM-4:30 PM CDT

(Press release, Astellas, MAY 18, 2026, View Source [SID1234665837])

On May 18, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical trial for the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). This approval marks the successful advancement of Opamtistomig’s clinical development in EP-NEC from late-line monotherapy to first-line combination therapy — Opamtistomig had previously received CDE approval for a pivotal single-arm registration trial in 3L+ EP-NEC patients; this Phase III approval further expands Opamtistomig’s addressable patient population in EP-NEC, potentially reshaping the treatment landscape for this malignancy.

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This randomized, double-blind, multicenter Phase III study is led by Professor Lin Shen of Peking University Cancer Hospital. The approval was based on the promising efficacy and favorable safety profile demonstrated by Opamtistomig in a successfully completed Phase Ib/II proof-of-concept study. Detailed results are planned to be presented at the 2026 ESMO (Free ESMO Whitepaper) Congress.

As an integral part of the overall EP-NEC development strategy, Leads Biolabs plans to submit a Biologics License Application (BLA) in the third quarter of 2026 for Opamtistomig as a single agent for the treatment of advanced EP-NEC in the third-line or later setting. In parallel, Leads Biolabs is advancing multiple proof-of-concept studies and preparing to initiate at least two additional Phase III clinical trials for Opamtistomig, exploring its application across 13 solid tumor indications, including first-line NSCLC, first-line BTC, small cell lung cancer, and ovarian cancer, thereby building a comprehensive, multi-tumor, multi-stage development layout. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC) and extrapulmonary neuroendocrine carcinoma (EP-NEC).

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The Phase Ib/II data for Opamtistomig in first-line treatment of EP-NEC are encouraging. In our communications with the CDE, we have seen the regulatory agency’s strong focus on unmet clinical needs and its recognition of Opamtistomig’s clinical value. Based on the clear regulatory feedback, we are rapidly implementing the pivotal Phase III study protocol, and we look forward to validating its potential to extend patient survival through a high-quality trial, bringing this innovative therapy to EP-NEC patients as soon as possible."

About EP-NEC

EP-NEC is a highly aggressive, immunologically "cold" tumor. To date, no drug has received regulatory approval for this indication worldwide. The current first-line standard treatment for advanced EP-NEC remains platinum-based chemotherapy, with an objective response rate (ORR) of 30%-50% and a median overall survival (mOS) of approximately 1 year, underscoring a pressing unmet need for new therapeutic options.

About Opamtistomig

Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, MAY 18, 2026, View Source [SID1234665835])