On December 10, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company developing first-in-class therapies for difficult-to-treat cancers, reported a clinical supply agreement with BeOne Medicines, a global oncology company. This agreement will supply a global, multi-center Phase 1b/2a clinical trial to evaluate Senhwa’s lead compound Pidnarulex (CX-5461) in combination with BeOne’s tislelizumab, a PD-1 inhibitor, in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

This agreement represents a significant milestone for Senhwa as CX-5461 enters the immuno-oncology field, and it also underscores the company’s commitment to advancing strategic combination therapies that break through the limitations of immunotherapy —bringing new hope to cancer patients worldwide.

Senhwa Biosciences: Driving a New Era in Immuno-Oncology

"This agreement represents a major step forward for Senhwa as we expand into the heart of immuno-oncology," said Benny T. Hu, Chairman of Senhwa Biosciences. "By leveraging the unique mechanism of action of CX-5461 in modulating the tumor microenvironment, we hope to discover and confirm new treatment options for patients who do not currently benefit from existing treatment options, while increasing international recognition and building long-term strategic value for the company," added by Chairman Hu.

Under the terms of the agreement, BeOne Medicines will provide tislelizumab for the combination study, while Senhwa will supply CX-5461 and lead clinical and regulatory operations. The study will enroll patients at multiple sites in the United States and Taiwan, assessing safety, tolerability, and preliminary efficacy of the CX-5461 plus tislelizumab combination.

By modulating the tumor microenvironment, CX-5461 breaks through the barriers of immunotherapy, opening new possibilities for cancer treatment

Discovered and developed by Senhwa, CX-5461 is the world’s first G-quadruplex stabilizer with significant clinical data—a novel therapeutic class designed to selectively disrupt genomic stability in tumor cells through replication stress induction.

Recent preclinical and clinical findings suggest that CX-5461 not only exerts direct cytotoxic activity but also modulates the tumor microenvironment, enhancing immune recognition and response.

By converting immunologically "cold" tumors into "hot" ones, CX-5461 may sensitize previously resistant tumors to checkpoint blockade and broaden the clinical utility of immunotherapy.

The "cold-to-hot" tumor concept represents one of the most promising frontiers in cancer immunology. CX-5461’s differentiated mechanism positions Senhwa to play a leading role in improving the efficacy of the immune checkpoint inhibitors approved by FDA with only 20-30% response rates.

Global Immunotherapy Market: Expanding Horizons

According to Precedence Research, the global cancer immunotherapy market is expected to grow from USD 136.4 billion in 2025 to USD 338.4 billion by 2034, representing a compound annual growth rate (CAGR) of 10.65%. Similarly, Grand View Research projects that the broader immunotherapy market will exceed USD 486 billion by 2030.

As major pharmaceutical companies approach a looming patent cliff—most notably with the immune checkpoint inhibitor blockbuster KEYTRUDA, which is expected to lose its exclusivity in 2028—the industry is ramping up efforts to secure next-generation immuno-oncology assets through strategic partnerships, mergers, and acquisitions.

With its differentiated pipeline, established collaboration with the U.S. National Cancer Institute (NCI), and now entering the supply agreement with BeOne Medicines, Senhwa Biosciences is uniquely positioned at the intersection of scientific innovation and global capital markets. The company aims to play a pivotal role in the next wave of expansion and innovation in precision medicine and immuno-oncology by partnering with global pharmaceutical companies and to drive sustainable growth and long-term value creation for its stakeholders.

(Press release, Senhwa Biosciences, DEC 10, 2025, View Source [SID1234661354])

On December 10, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present data on potential treatments for pancreatic and gastric/gastroesophageal junction (G/GEJ) cancer at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium taking place January 8-10, 2026 in San Francisco, California. Highlights include a late-breaking oral presentation of cohort results from the Phase 2 ILUSTRO study of first-line zolbetuximab in combination with chemotherapy and immunotherapy in claudin 18.2-positive, HER2-negative, locally advanced or metastatic G/GEJ cancer, as well as new Phase 1 data from ASP3082 (setidegrasib), an investigational KRAS G12D targeted protein degrader, in pancreatic cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"At Astellas, we are harnessing next-generation treatment modalities and a precision biomarker-driven approach to deliver treatments that make a meaningful difference for patients with gastrointestinal cancers. We’re excited to share data at ASCO (Free ASCO Whitepaper) GI from our growing portfolio of assets in GI cancers – which showcase our commitment to better understanding how to treat these diseases – including emerging data from zolbetuximab as well as progress on ASP3082 (setidegrasib), our investigational KRAS G12D targeted protein degrader. Together with the passionate GI cancer community of patients, physicians, and advocates, we are working to transform outcomes for patients and pave the future of cancer care."

Astellas Presentations at ASCO (Free ASCO Whitepaper) GI 2026

Zolbetuximab

Presentation Title

Presenter

Presentation Details

Phase 2 ILUSTRO trial of first-line
zolbetuximab plus mFOLFOX6 and
nivolumab in patients with claudin
18 isoform 2-positive, human
epidermal growth factor receptor 2-
negative, locally advanced or
metastatic gastric or
gastroesophageal junction
adenocarcinoma

K. Shitara

Type: Oral presentation

Abstract Number: LBA284

Date: January 8, 2026,
8:47 a.m. – 8:57 a.m. PST

Determinants of biomarker testing
and treatment selection by
oncologists caring for patients with
gastric or gastroesophageal
junction adenocarcinoma

R. Fuldeore

Type: Poster

Abstract Number: 453

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

Zolbetuximab + pembrolizumab
and chemotherapy as first-line
treatment for patients with
CLDN18.2-positive, HER2-
negative, PD-L1-positive locally
advanced unresectable or
metastatic G/GEJ
adenocarcinoma: Phase 3, double-
blind, randomized trial (LUCERNA)

K. Shitara

Type: Poster

Abstract Number: TPS473

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

Assessment of the impact of proton
pump inhibitor exposure on
survival outcomes in patients with
gastric or gastroesophageal
junction adenocarcinoma treated
with zolbetuximab plus
chemotherapy

A. Yamada

Type: Poster

Abstract Number: 349

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

A real-world study of claudin 18.2
association with molecular
subtypes, mutations/biomarkers,
immune landscapes, and gene
signatures and prognostic value in
pancreatic ductal adenocarcinoma

G. Zhang

Type: Poster

Abstract Number: 744

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

Treatment patterns and outcomes
of patients diagnosed with
metastatic pancreatic
adenocarcinoma

R. Fuldeore

Type: Poster

Abstract Number: 685

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

ASP3082 (setidegrasib)

Presentation Title

Presenter

Presentation Details

Efficacy and safety of setidegrasib
(ASP3082) monotherapy or in
combination with mFOLFIRINOX in
patients with pancreatic ductal
adenocarcinoma

A. Kasi

Type: Poster

Abstract Number: 704

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

Phase 1 evaluation of setidegrasib
(ASP3082), a first-in-class selective
protein degrader, in patients with
KRAS G12D-mutant pancreatic
ductal adenocarcinoma:
Pharmacokinetics and biomarker
insights

W. Park

Type: Poster

Abstract Number: 775

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

(Press release, Astellas, DEC 10, 2025, View Source [SID1234661353])

On December 10, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the presentation of a Phase II clinical study that included a longer-term efficacy data evaluating ivonescimab (a PD-1/VEGF bispecific antibody) combined with chemotherapy as a first-line treatment for locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) at the 2025 European Society for Medical Oncology Immuno-Oncology Congress (ESMO IO) in London, UK.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Based on positive efficacy and safety profile, the ivonescimab combination therapy for first-line TNBC was previously included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). Currently, the multicenter, randomized, double-blind Phase III clinical trial (HARMONi-BC1/AK112-308) for this indication is currently ongoing.

Preliminary results from this study were previously announced at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 and the 2024 San Antonio Breast Cancer Symposium (SABCS). With the follow-up period now extended to 22.1 months, the study further validates the efficacy and safety profile of the ivonescimab regimen in first-line TNBC treatment.

As of July 15, 2025, a total of 36 patients with TNBC were enrolled. The median age was 55 years, 83.3% of patients had a PD-L1 combined positive score (CPS) <10, and 55.6% had received prior taxane-based neo/adjuvant therapy. As of the data cutoff, 35 patients had undergone at least one post-baseline tumor assessment and were included in the efficacy analysis set. The results showed that the ivonescimab combined with chemotherapy regimen demonstrated efficient tumor relief, disease control, and survival benefits in all PD-L1 subgroups of TNBC patients receiving first-line treatment. The key results are:

The objective response rate (ORR) for the overall population was 80.0%, the disease control rate (DCR) was 100.0%, and the median duration of response (mDOR) was 12.2 months; the median progression-free survival (mPFS) was 15.2 months, with a 12-month PFS rate of 56.3%.
In the CPS≥10 subgroup, the ORR was 83.3%, the DCR was 100%, the mDOR was 12.2 months; the mPFS was 15.9 months, with a 12-month PFS rate of 66.7%.
In the CPS<10 subgroup, the ORR was 79.3%, the DCR was 100%, the mDOR was 9.9 months; the mPFS was 13.04 months, with a 12-month PFS rate of 54.3%.
In the CPS≥1 subgroup, the ORR was 72.2%, the DCR was 100%, the mDOR was 12.2 months; the mPFS was 15.9 months, with a 12-month PFS rate of 63.8%.
Overall survival (OS) data is not yet mature.
Ivonescimab combined with chemotherapy as first-line treatment for TNBC demonstrated a good safety profile. No treatment-related adverse events (TRAEs) led to discontinuation or death in this study, and the most common TRAEs were mostly grade 1-2.

(Press release, Akeso Biopharma, DEC 10, 2025, View Source [SID1234661352])

On December 10, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported positive data from the Phase III lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer. At the pre-specified interim analysis, adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (invasive disease-free survival [iDFS]) compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014). The lidERA results are being presented at the 2025 San Antonio Breast Cancer Symposium and are included in the official press program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In early ER-positive breast cancer, challenges with disease recurrence and treatment adherence mean there is an urgent need for more effective, tolerable endocrine therapies," said Aditya Bardia, M.D., M.P.H., director, breast oncology program, professor of medicine at the David Geffen School of Medicine at University of California, Los Angeles (UCLA), director of translational research integration at the UCLA Health Jonsson Comprehensive Cancer Center, and lidERA principal investigator. "After almost 25 years, a new medicine – giredestrant – has demonstrated superiority over existing endocrine therapies in the curative setting, highlighting its potential as a new standard-of-care endocrine therapy for patients with breast cancer."

"The substantial efficacy observed with giredestrant in the lidERA trial underscores its potential to become a new standard-of-care endocrine therapy in ER-positive early-stage breast cancer, where the chance for cure is highest," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We look forward to sharing these results with health authorities around the world with the aim of bringing this new treatment option to patients as soon as possible."

At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the SoC ET arm. The iDFS benefit was consistent across all clinically relevant subgroups. Overall survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed. Follow-up for OS will continue to the next analysis. Giredestrant also demonstrated a 31% risk reduction of distant recurrence-free interval (HR=0.69, 95% CI 0.54-0.89) – another key secondary endpoint. Giredestrant was well tolerated; adverse events were manageable and consistent with its known safety profile.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage. Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

Giredestrant is the first and only oral selective estrogen receptor degrader (SERD) to show superior iDFS in the adjuvant setting and lidERA is the second positive Phase III readout for giredestrant following the evERA Breast Cancer results in the metastatic setting. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels). This growing body of evidence supports the potential of giredestrant to meaningfully improve outcomes compared with standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.

Genentech’s extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the lidERA Breast Cancer study
lidERA Breast Cancer [NCT04961996] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Over 4,100 patients were enrolled in the study.

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.

About giredestrant
Giredestrant is an investigational, oral, next-generation selective estrogen receptor degrader (SERD) and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

About estrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

(Press release, Genentech, DEC 10, 2025, View Source [SID1234661351])

On December 10, 2025 Privo Technologies, Inc., reported that the first patient has been dosed in its first-in-human clinical trial evaluating PRV131, a nanoengineered intratumoral cisplatin injectable for the treatment of T1–T3 oral squamous cell carcinoma (OSCC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Phase 1/2 Dose Escalation and Dose Optimization Run-In Study (Arm 3 of CLN-004) is designed to refine dosing by evaluating safety, preliminary efficacy, tolerability, and pharmacokinetics of PRV131 across selected dose levels as a neoadjuvant therapy. With the intention of debulking tumors prior to surgery, the goal of PRV131 is to improve surgical outcomes, preserve oral tissue, and reduce the morbidity associated with traditional surgical approaches.

The trial has now opened at the first clinical site, where the inaugural patient received treatment with PRV131, marking a key milestone in the development of novel locoregional therapies for head and neck cancer.

About PRV131

Built on Privo’s proprietary PRV Platform technology, PRV131 is a nanoengineered intratumoral injectable suspension designed to deliver high-concentration cisplatin directly into solid tumors while minimizing systemic exposure. This inaugural dosing represents an important expansion of the PRV program beyond topical and intraoperative patches (e.g., PRV111 and PRV211) toward intratumoral delivery of cisplatin for patients with oral cavity malignancies. PRV131 is engineered to address significant unmet needs in oral cavity cancer by:

Shrinking or debulking tumors prior to surgery to improve functional and cosmetic outcomes
Delivering high intratumoral drug concentration while limiting off-target toxicity
Potentially preserving form and function of the oral cavity, which can be severely impacted by standard surgical interventions
Preclinical studies have demonstrated that PRV131 can shrink or eliminate several solid tumor types, including squamous cell carcinomas, while generating durable responses. In companion animal studies conducted in dogs with large, naturally occurring tumors, PRV131 reduced tumor volumes by over 80% with no observed systemic toxicity.

"We are incredibly pleased to begin dosing patients with PRV131 in this first-in-human study," said Dr. Manijeh Goldberg, PhD, Founder and CEO of Privo Technologies. "Patients with oral cavity cancer often face invasive surgeries that can dramatically affect their ability to speak, eat, and live comfortably. PRV131 is designed to shrink tumors directly at the site, helping preserve critical oral structures and maintain function, offering the potential for meaningful improvements in quality of life. This milestone represents an important step in our mission to transform local cancer treatment with precise, targeted, nanoengineered chemotherapy."

(Press release, Privo Technologies, DEC 10, 2025, View Source [SID1234661350])