On June 2, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported new clinical data from its emerging breast cancer pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, BeOne Medicines, JUN 2, 2025, View Source [SID1234653661]). Poster presentations feature preliminary results of the dose escalation studies of two investigational molecules: BG-C9074, a novel B7-H4-targeting antibody-drug conjugate (ADC) in patients with advanced solid tumors, including breast cancer, and BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), in HR+/HER2- breast cancer patients with prior CDK4/6i exposure.

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"Presenting the first clinical data for two novel breast cancer candidates at ASCO (Free ASCO Whitepaper) 2025 marks a pivotal moment for BeOne," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "These early results highlight the strong potential of our B7-H4-targeting ADC and CDK2 inhibitor to address critical gaps in breast cancer treatment. Alongside our advancing CDK4 inhibitor, they represent just the beginning of a pipeline built on targeted, biology-driven innovation. As we debut our new identity as BeOne, this milestone reflects the momentum behind our science and our commitment to delivering impactful therapies to cancer patients worldwide."

BeOne is advancing a robust pipeline of differentiated investigational medicines for breast cancer that may both effectively combat the disease and potentially improve quality of life for patients receiving treatment.

BG-C9074, a B7-H4-targeting ADC (Abstract #3033)

BeOne presented initial results of the ongoing first-in-human, Phase 1a dose escalation study of BG-C9074 monotherapy in 78 patients with advanced solid tumors, of which more than a quarter were breast cancer patients. BG-C9074, an investigational topoisomerase I inhibitor ADC that targets the B7-H4 protein, which is broadly expressed in breast and gynecologic cancers, is designed with an innovative drug linker to deliver a potent cancer-killing drug directly to the cancer cells.

With limited follow-up among the 56 efficacy-evaluable patients, preliminary clinical responses were observed at multiple dose levels across various tumor types without selection for B7-H4 expression in these heavily pretreated patients. Confirmed overall response rate (ORR) was 16.1% (9/56; 95% CI: 7.6%–28.3%), with 9 confirmed partial responses; unconfirmed ORR was 25.0% (14/56; 14.4%-38.4%) (n=14 partial responses). Confirmed disease control rate (DCR) was 73.2% (59.7%-84.2%) and confirmed clinical benefit rate (CBR) was 17.9% (8.9%-30.4%). Pharmacokinetics (PK) were observed to be approximately dose-proportional across dose levels.

BG-C9074 showed a manageable safety and tolerability profile in patients with B7-H4 advanced solid tumors, including breast cancer. There were 5 dose-limiting toxicities (DLTs) reported among 3 dose levels, all related to treatment: grade 3 fatigue (n=1); grade 3 febrile neutropenia (n=2); and grade 4 platelet count decreased (n=2). The most common treatment-emergent adverse events (TEAEs) were nausea, fatigue, and neutropenia*. The most common grade ≥3 TEAEs were neutropenia and thrombocytopenia†. There were no TEAEs leading to treatment discontinuation or death.

These data support the continued development of BG-C9074 in patients with advanced solid tumors. (NCT06233942)

BG-68501, a CDK2 inhibitor (Abstract# 3115)

Dose-escalation data from the first-in-human, Phase 1a study of a novel CDK2 inhibitor, BG-68501, were presented as a poster today. BG-68501 is designed to address elevated CDK2 activity as well as cyclin E1-driven upregulation, two key resistance mechanisms that often limit the effectiveness of CDK4/6 inhibitors in treating HR+/HER2- breast cancer. CDK inhibitors target checkpoint proteins that control cell division to stop the growth of cancer cells.

A total of 57 enrolled patients with advanced solid tumors, including 19 patients with HR+/HER2- metastatic breast cancer, received BG-68501 as monotherapy or in combination with fulvestrant in escalating dose cohorts (all received prior CDK4/6i).

Of the 37 efficacy-evaluable patients (all with monotherapy), unconfirmed overall response rate (ORR) was 5.4% (2/37; 95% CI: 0.7%–18.2%). Two extensively pretreated patients (5.4%) experienced unconfirmed partial response (PR), 15 patients (40.5%) had stable disease (SD), 15 patients (40.5%) had progressive disease (PD), and 5 patients (13.5%) were not evaluable/not assessed. Of the 2 patients with PR, both were breast cancer patients, and one was ongoing with treatment at the time of data cutoff, while the other had discontinued treatment. Unconfirmed clinical benefit rate (CBR) was 8.1% (3/37; 95% CI: 1.7%-21.9%) and unconfirmed disease control rate (DCR) was 45.9% (17/37; 95% CI: 29.5%-63.1%). BG-68501 demonstrated a linear PK profile consistent with preclinical data and signs of pharmacodynamic responses.

BG-68501 demonstrated a manageable safety and tolerability profile, with no DLTs observed to date during dose escalation. The most common TEAEs were vomiting, nausea, and fatigue, and TEAEs leading to treatment discontinuation occurred in 4 patients (7%) across all dose levels. There were no TEAEs leading to death.

The data support continued development of BG-68501 as a next-line option for tumors with CDK2 dependency. (NCT06257264)

For additional information about our presence at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit our meeting hub: congress.beonemedicines.com.

BeOne will host an investor R&D Day on June 26 at 8:30 am ET covering its deep and broad global innovation pipeline and platforms, as well as the Company’s vision, differentiated capabilities, and value creation drivers. A live webcast will be accessible from the investors section of BeOne’s website at View Source, View Source, or View Source An archived replay will be available for 90 days following the event.

About Our Breast Cancer Pipeline

BeOne is advancing a robust portfolio of investigational medicines for breast cancer, including three molecules in clinical development – two cyclin-dependent kinase (CDK) inhibitors, BGB-43395, a CDK4 inhibitor, and BG-68501, a CDK2 inhibitor, and an antibody-drug conjugate (ADC), BG-C9074. BeOne also plans to evaluate the potential of BCL2 inhibition in breast cancer, with next-generation BCL2 inhibitor, BGB-21447, expected to begin clinical testing in solid tumor indications soon. Multispecific antibodies and targeted protein degraders with potential applications in breast cancer are among the preclinical assets being developed.

About Breast Cancer

Breast cancer accounts for close to one in four cancer cases and one in six cancer deaths in women worldwide.1 Globally, breast cancer is the second most common cancer and the fourth highest cause of cancer mortality as well as the leading cause of cancer death in women.1 More than 2.3 million patients were diagnosed with breast cancer in 2022, and over 666,000 deaths were reported globally.1 Approximately two-thirds of breast cancer cases are the HR+/HER2- subtype.

On June 2, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that updated data from an ongoing, global Phase 1a/1b clinical trial (NCT06179069) evaluating zocilurtatug pelitecan, or ZL-1310, the Company’s potential first-in-class, Delta-like ligand (DLL3) antibody-drug conjugate (ADC) for patients with extensive-stage small cell lung cancer (ES-SCLC), will be presented today during a poster session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Zai Laboratory, JUN 2, 2025, View Source [SID1234653660]). The presentation includes updated results from the dose escalation portion and the first presentation of dose expansion data from a total of 89 enrolled patients across six dose cohorts.

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"Small cell lung cancer is an aggressive disease, with rapid disease progression and brain metastases developing in up to 70% of patients," said Manish R. Patel, M.D., Florida Cancer Specialists and Sarah Cannon Research Institute. "There remains a significant unmet need for effective and well-tolerated therapies in the relapsed setting. The updated Phase 1 results for ZL-1310 show strong anti-tumor activity, including intracranial responses with a manageable safety profile, reinforcing its potential as a meaningful treatment option for patients with previously treated extensive-stage small cell lung cancer."

Data from the ongoing Phase 1 monotherapy dose escalation and dose expansion portion of the study as of the data cut-off date of April 1, 2025, include results from 89 patients across six dose cohorts (0.8 mg/kg, 1.2 mg/kg, 1.6 mg/kg, 2.0 mg/kg, 2.4 mg/kg and 2.8 mg/kg). 74 patients had at least one post-baseline tumor assessment per RECIST v1.1.

All patients in the study had progressed following platinum-based chemotherapy, and 90% of patients had progressed after immune checkpoint inhibitors. Of all patients, 33% had failed two prior lines of therapy, and 20% had failed three or more prior lines of therapy, making this a highly pretreated population with limited therapeutic options. 10 patients received a prior DLL3 bi-specific antibody. A total of 30% of patients had brain metastases at baseline. This study included patients in the United States, Europe and China.

Key efficacy results include (n=74):

Across all dose levels in the 2L treatment setting (n=33), the unconfirmed objective response rate (uORR) in patients was 67% and the disease control rate (DCR) was 97%. The most promising combination of response and tolerability was observed in the 1.6 mg/kg arm (n=14) with a uORR of 79% and a DCR of 100%.

Across all doses and lines of therapy (n=74), of 38 patients with confirmed (n=27) and unconfirmed (n=11) ORR, 29 (76%) remain on study, with the longest responder surpassing nine months of treatment. Eighty-nine percent of patients experienced a reduction in their tumor burden. Of the 31 patients with stable disease, 27 (87%) remain on study.

Response rates declined with increased prior treatment burden and higher dose levels, consistent with more advanced disease and potential tolerability limitations above 2.0 mg/kg.

Of the 22 response-evaluable patients with baseline brain metastases, a 68% ORR was observed. In patients without prior cranial irradiation, ORR was 86%.

Responses were seen in patients following treatment with a prior DLL3 bi-specific across lines of therapy.

Median length of follow-up is immature at 3.4 months, making median duration of response not estimable.
Key safety findings include (n=89):

ZL-1310 continues to demonstrate a well-tolerated safety profile, particularly in doses less than 2.0 mg/kg.

In the dose cohort <2.0 mg/kg, Grade 3 or higher TRAEs occurred in 6% of patients and serious TRAEs in 4%. The most common TRAEs were anemia (Gr≥3 2%) and neutropenia (Gr≥3 4%). There were no treatment discontinuations and no Gr≥3 interstitial lung diseases (ILDs).

Across all dose cohorts, Grade 3 or higher TRAEs occurred in 23% of patients and serious TRAEs in 21%. The most common TRAEs were anemia (Gr≥3 11%) and neutropenia (Gr≥3 14%). There were five discontinuations due to TRAEs, all in the higher dose cohort. There were two cases of Gr≥3 treatment-related ILD, one at the 2.0 g/kg dose and one at the 2.4 mg/kg dose.
Based on the safety and efficacy data from this trial, Zai Lab plans to initiate a randomized registrational study in 2L ES-SCLC later this year, evaluating the selected dose of ZL-1310 versus standard of care. Zai Lab is also actively enrolling patients in a front-line SCLC study and in other neuroendocrine carcinomas, with data updates anticipated later this year.

"The safety and efficacy profile of ZL-1310 continues to highlight a compelling opportunity to significantly improve the outcomes for patients with extensive-stage small cell lung cancer and underscores its potential to become the first-in-class DLL3-targeted ADC in this setting," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "We are continuing to advance a clear strategy to expand the reach of ZL-1310 across multiple high-need DLL3-expressing solid tumor types, with our first regulatory submission targeted as early as next year."

Zai Lab will hold an investor conference call and webcast to highlight updated ZL-1310 data at ASCO (Free ASCO Whitepaper) and outline the next steps in clinical development.

Details regarding the webcast and conference call are as follows:

Date/Time: Monday, June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT, please register at:
Webcast presentation (preferred): View Source
Dial-in: View Source
Presenters: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab; Manish R. Patel, M.D., Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL; and Alex Spira, M.D., Ph.D., Co-Director, Virginia Cancer Specialists Research Institute

Details regarding the ZL-1310 poster presentation are as follows:

Title: ZL-1310, a DLL3 ADC, in patients with extensive stage small cell lung cancer: Ph1 trial update
Presenter: Manish R. Patel, M.D., Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL
Session Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date/Time: Monday, June 2, 2025, from 1:30 p.m. – 4:30 p.m. CT
Location: McCormick Place Convention Center, Hall A – Posters and Exhibits
Published Abstract Number: 3041
Poster Board: 356

About Small Cell Lung Cancer and ZL-1310

Small cell lung cancer (SCLC) is one of the most aggressive and lethal solid tumors, accounting for ~15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage3.

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

ZL-1310 received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in January 2025, recognizing its potential to treat patients with SCLC.

About the Webcast and Conference Call

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

On June 2, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the results of the Phase III SERENA-6 trial – sponsored by AstraZeneca – demonstrate the clinical value of the Guardant360 CDx test in a circulating tumor DNA-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of radiological disease progression in breast cancer (Press release, Guardant Health, JUN 2, 2025, View Source [SID1234653659]). Study results were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago and were published in The New England Journal of Medicine.

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SERENA-6 is the first global, double-blind, registrational Phase III trial to use a ctDNA-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression is detected in imaging scans. The novel trial design used ctDNA monitoring with the Guardant360 liquid biopsy test at the time of routine tumor scans to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations.

"SERENA-6 is a landmark study that is creating a new paradigm using liquid biopsy to enable a switch to a new treatment as soon as you see the cancer showing signs of resistance," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "This use of the Guardant360 CDx test highlights how we are pushing the boundaries of what can be done with liquid biopsy in characterizing disease and potential drug efficacy, providing insights that could potentially change clinical practice and improve outcomes in patients with advanced breast cancer."

Following detection of an ESR1 mutation without radiological disease progression, the endocrine therapy of patients was switched to AstraZeneca’s camizestrant from ongoing treatment with an aromatase inhibitor (AI), while continuing combination with the same cyclin-dependent kinase (CDK) 4/6 inhibitor. The trial demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors had an emergent ESR1 mutation as detected by Guardant360 CDx.

About Guardant360 CDx

The first FDA-approved blood test for complete genomic testing, Guardant360 CDx is approved as a companion diagnostic fur multiple therapies in non-small cell lung cancer. It is also the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations. The test is broadly covered by Medicare and commercial insurers, representing over 300 million lives. For more information, visit the Guardant360 CDx website.

On June 2, 2025 Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates, reported a manufacturing partnership with Sterling Pharma Solutions, a global contract development and manufacturing organisation, to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology antibody-drug conjugate (ADC) candidate, KIVU-107 (Press release, Kivu Bioscience, JUN 2, 2025, View Source [SID1234653658]).

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Under the agreement, Sterling will manufacture cGMP clinical material for KIVU-107 at its dedicated bioconjugation facility in Deeside, UK. The collaboration includes process familiarisation, analytical development, process optimisation, and scale-up activities in preparation for a cGMP manufacturing campaign.

"We chose Sterling as our manufacturing partner based on their deep expertise in ADC development, proven track record of clinical supply, and commitment to quality," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. "This partnership marks an important milestone as we advance KIVU-107 toward first-in-human studies and deliver on our mission to bring kinder, gentler and efficacious next-generation ADC therapies to patients."

KIVU-107 is a potential first-in-class antibody-targeted conjugate which enables site-specific conjugation. The resulting structure positions the linker-payload in a natural cavity in the antibody, providing excellent stability, reduced hydrophobicity, and an increased therapeutic index relative to first-generation ADC therapies.

"Our team at Deeside has extensive experience supporting complex ADC programs from early development through clinical manufacturing," said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions. "We’re excited to support Kivu to bring this promising new oncology candidate into the clinic, leveraging our expertise and investment in world-class ADC development and clinical manufacturing capabilities."

Sterling’s 6,500-square-metre Deeside facility offers a range of ADC services, from discovery-stage development through to clinical supply. In October 2024, Sterling announced a £10 million investment at the site to double its GMP manufacturing capacity, as the second phase of an ongoing strategy to increase the capabilities that it can offer customers.

On June 2, 2025 Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, reported the launch of a new multi-year collaboration with Novartis aimed at transforming cancer care through the development of proprietary AI-powered workflows within the Viz Oncology Suite (Press release, Novartis, JUN 2, 2025, View Source [SID1234653657]). This strategic alliance will focus on improving the identification and stratification of patients diagnosed with prostate and breast cancers based on key risk factors, accelerating access to guideline-based precision treatments.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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For patients with cancer, every day matters. Yet too often, diagnosis and treatment are delayed by fragmented systems, manual reviews, and complex care journeys. These inefficiencies can lead to missed diagnoses, delayed access to life-extending therapies, and worse outcomes. This collaboration aims to address that, using AI to help ensure patients are surfaced and treated earlier, with care that’s timely, coordinated, and personalized.

"We are excited to be partnering with Novartis, an innovative medicines company and a leader in oncology, to accelerate access to timely, guideline-based care for patients facing prostate and breast cancer," said Chris Mansi, MD, CEO and co-founder of Viz.ai. "This collaboration is part of our broader strategic expansion into oncology, furthering Viz.ai’s mission to fundamentally transform healthcare through intelligent care coordination."

As part of the collaboration Viz.ai will be developing two new AI-powered solutions:

Viz Prostate Cancer, designed to streamline the identification of eligible patients for guideline-based treatment and support timely referrals to an appropriate specialist. Only one in four patients receives guideline-recommended therapy for prostate cancer, and thousands of patients with advanced disease who are eligible for potential life-extending treatments are never identified.1,2
Viz Breast Cancer, designed to support breast oncologists by automating patient review, aggregating risk-relevant data, surfacing therapeutic guidelines, and facilitating coordination among multidisciplinary care teams. Breast cancer is the most widely diagnosed cancer in the United States, with patient care journeys that are complex, time-consuming, and often fragmented.3
"Earlier diagnosis and interventions can positively impact patient outcomes. At Novartis, we lead the industry in fostering bold partnerships and initiatives that support early screening and diagnosis; we are also leveraging innovative, data-driven technologies to help connect patients with appropriate care as quickly as possible," said Rodney Gillespie, Head of Oncology, Novartis US. "By sharing key insights with Viz.ai, we will develop AI-powered solutions to quickly help reach patients who could benefit from guideline-based targeted treatments for prostate and breast cancer, helping significantly expedite their care."

"Too often, patients with cancer are identified late or fall through the cracks of an increasingly complex care system," said Ethan M. Basch, MD, Chief of Oncology and Cancer Hospital Physician-in-Chief at UNC. "AI-powered tools bring the potential to optimize how we detect, triage, and treat cancer—by delivering the right care, to the right patient, at the right time."

With this collaboration and expansion into oncology, Viz.ai is building on its commitment to create a connected, intelligent healthcare AI layer that delivers better care for every patient, everywhere. Learn more about Viz Oncology by visiting viz.ai/pilot-programs.