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Hengrui Pharma Presents More Than 90 Oncology Studies at ASCO 2026, Highlighting Progress Across Multiple Tumor Types

On June 1, 2026 Hengrui Pharma reported more than 90 studies spanning multiple tumor types and therapeutic modalities at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting was held in Chicago from May 29 to June 2 (local time).

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According to statistics, 94 Chinese research projects were selected for oral presentations at ASCO (Free ASCO Whitepaper) this year, including 12 late-breaking abstracts, marking the third consecutive year of growth. At 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, Hengrui Pharma presented 91 accepted studies and 11 oral presentations featuring innovative therapies, underscoring the breadth of the company’s oncology pipeline and ongoing investment in innovative drug development.

As a leading innovative pharmaceutical company in China, Hengrui continues to focus on oncology research and drug development. For 16 consecutive years, Hengrui has shared data from its oncology portfolio at the ASCO (Free ASCO Whitepaper) Annual Meeting. This year, the company’s research program encompasses multiple key areas, including gastrointestinal cancers, breast cancer, lung cancer, urological cancers, gynecological cancers, and supportive cancer care, covering 11 approved medicines, 10 pipeline candidates, and one Class 2 new drug (NMPA classification). These programs are supported by more than 10 technology platforms covering small molecules, ADCs, bispecific and multispecific antibodies, and degraders. Together, these platform-based R&D capabilities support a broad oncology pipeline encompassing multiple therapeutic approaches across different tumor types.

Breast Cancer: New Data Support Multiple Emerging Treatment Strategies

For triple-negative breast cancer, the HELEN-Trio 011 study led by Professor Zhenzhen Liu of Henan Cancer Hospital showed that the pathological complete response (pCR) rate for neoadjuvant therapy with camrelizumab combined with chemotherapy reached 57.5%, significantly outperforming the pCR of 45.4% observed with chemotherapy alone. In the field of neoadjuvant therapy for HER2-positive early breast cancer, the HELEN HER-013 study was the first to demonstrate that the chemotherapy-de-escalated regimen of nanoparticle albumin-bound paclitaxel, trastuzumab, and the tyrosine kinase inhibitor pyrotinib (nab-PHPy) is noninferior to standard TCHP, offering a new treatment option for patients who cannot tolerate severe hematologic toxicity.

Gastrointestinal Cancers: ADC and Immunotherapy Combination Treatments Show Promise

In the field of colorectal cancer, the HORIZON-CRC01 study led by Professor Jin Li of Shanghai GoBroad Cancer Hospital Affiliated to China Pharmaceutical University and Professor Ying Yuan of The Second Affiliated Hospital of Zhejiang University School of Medicine demonstrated that the new-generation anti-HER2 ADC, trastuzumab rezetecan, when used to treat patients with HER2-positive, RAS and RAF wild-type advanced colorectal cancer who have progressed after standard second-line therapy, achieved a median progression-free survival (PFS) of 5.5 months, compared to 2.8 months with conventional chemotherapy, suggesting a potential new treatment option for patients whose disease has progressed following standard therapies. In the field of liver cancer, the CARES-336 study, co-led by Academician Jia Fan from Zhongshan Hospital Affiliated to Fudan University and Professor Shukui Qin from Tsientang Institute for Advanced Study, has for the first time demonstrated that the "Camrelizumab + Apatinib" regimen combined with transarterial chemoembolization (TACE) significantly prolongs median PFS compared to TACE alone (by BIRC per mRECIST, 11.1 months vs. 8.3 months), supporting the potential use of this combination approach in patients with unresectable hepatocellular carcinoma (uHCC).

Urological Cancers: Dual Breakthroughs in Prostate and Bladder Cancers

The FUZUPRO study, led by Professor Dingwei Ye of Fudan University Shanghai Cancer Center, demonstrated that first-line treatment with fluzoparib combined with abiraterone acetate and prednisone for metastatic castration-resistant prostate cancer (mCRPC) resulted in a median radiographic PFS of 24.8 months, compared to 19.9 months with the standard regimen. Another study demonstrated that the anti-Nectin-4 ADC SHR-A2102 combined with adebrelimab achieved a pCR of 48.1% and a pathological downstaging rate of 59.3% in the perioperative treatment of muscle-invasive bladder cancer, including those with renal dysfunction.

Supportive Cancer Care: Additional Evidence for New Antiemetic Drug

The Phase III PROTECT study, led by Professor Li Zhang and Professor Yuhong Li of the Sun Yat-sen University Cancer Center, demonstrated that Fosrolapitant and Palonosetron Hydrochloride for Injection—a novel, ultra-long-acting antiemetic developed in-house by Hengrui—achieved significantly higher complete response rates than the standard regimen during the acute, delayed, and overall phases for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy. These findings add to the growing body of clinical evidence supporting its use in supportive cancer care.

Hengrui Pharma currently markets 16 approved oncology medicines in China and is advancing nearly 60 oncology candidates across its research portfolio. The company is conducting more than 150 clinical trials worldwide across its key oncology development programs.

Hengrui’s expanding presence at the ASCO (Free ASCO Whitepaper) Annual Meeting reflects continued progress across its oncology pipeline and broader clinical development efforts. The company’s research presentations this year span multiple tumor types and therapeutic modalities, highlighting both approved medicines and investigational candidates across its oncology portfolio.

As oncology research continues to evolve globally, Hengrui remains focused on translating scientific innovation into potential clinical benefit for patients through sustained investment in research and development.

(Press release, Hengrui Pharmaceuticals, JUN 1, 2026, View Source [SID1234666336])

Haisco Announces Licensing and Research Collaboration Agreement with Lilly to Develop Innovative Medicines Across Multiple Therapeutic Areas

On June 1, 2026 Haisco Pharmaceutical Group Co., Ltd. ("Haisco") (Ticker Code: 002653) reported a licensing and research collaboration with Eli Lilly and Company ("Lilly") to develop innovative medicines across multiple therapeutic areas.

Under the agreement, Haisco will be responsible for the discovery and identification of up to five innovative target programs, while Lilly will lead IND-enabling studies, clinical development, and commercialization. Lilly will obtain exclusive worldwide rights to certain programs, and exclusive rights outside mainland China, Hong Kong, Macau, and Taiwan (the "Haisco Territory") for certain other programs, while Haisco will retain rights within the Haisco Territory for those programs.

"This collaboration is highly aligned with our international development strategy and is expected to generate sustainable value and long-term returns," said Dr. Pangke Yan, chief executive officer of Haisco, "By partnering with a global biopharmaceutical leader such as Lilly, Haisco aims to accelerate the global development of innovative therapies and deliver high-quality treatment options to patients worldwide."

This collaboration reflects the first license and research collaboration between Haisco and Lilly. By leveraging each party’s strengths in innovative drug development, the two companies will work together to accelerate the global advancement of innovative therapeutics.

Haisco will be eligible to receive up to $87M in upfront and near-term payments, up to $2,967M in all remaining downstream milestones, as well as single-digit tiered royalties on future product sales.

(Press release, Haisco Pharmaceutical, JUN 1, 2026, View Source [SID1234666335])

Citius Oncology Highlights Phase 1 Data in an Investigator-Initiated Study of LYMPHIR® (denileukin diftitox-cxdl) in Combination with Pembrolizumab in Recurrent or Refractory Gynecologic Malignancies

On June 1, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported Phase 1 clinical data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies. The poster presentation (Abstract #2564) was presented by investigators from the University of Pittsburgh Medical Center (UPMC) Magee-Womens Hospital.

"LYMPHIR’s ability to transiently deplete immunosuppressive regulatory T-cells may help address immune resistance in the tumor microenvironment and enhance the effect of checkpoint inhibitors. The encouraging clinical signals and tolerability profile observed in this study support continued clinical evaluation of this "chemo-free" immunomodulatory approach, especially in tumors where resistance to checkpoint inhibitors remains a significant challenge," said Dr. Myron S. Czuczman, Chief Medical Officer of Citius Oncology.

The open-label Phase 1 study evaluated LYMPHIR in combination with pembrolizumab in 25 heavily pre-treated patients (21 evaluable for efficacy) with recurrent or metastatic solid tumors, primarily gynecologic malignancies. Enrolled patients had received a median of five prior therapies, and more than half had previously received anti-PD-1 or PD-L1 therapy.

Key Efficacy and Safety findings presented at ASCO (Free ASCO Whitepaper) included:

24% Overall Response Rate (ORR) among the 21 efficacy-evaluable patients (5 partial responses).
Median duration of response (mDOR) had not yet been reached because only 1 of the 5 partial responders had progressed at the time of analysis (80% of PRs were continuing to experience clinical benefit). The current duration of response times (time since PR was achieved) were 4.2-35 months with a median of 21.1 months.
33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors, including one patient with an ongoing response greater than three years.
48% of efficacy-evaluable patients (10 of 21) achieved clinical benefit, defined as complete response (CR), partial response (PR), or durable stable disease lasting at least six months:
Median progression-free survival (mPFS) of 20.5 months (95% CI: 6.5 – NA) among the 10 patients who achieved clinical benefit; overall mPFS across all 21 efficacy-evaluable patients was 5.8 months (95% CI: 2.2 – NA);
5 patients had a PFS of > 20 months including 1 patient with > 30 months PFS;
Of the 24/25 pts evaluable for dose limiting toxicities (DLTs), only 1 case of reversible Gr 3 capillary leak syndrome (CLS) was observed at the highest dose level. A maximum tolerated dose was not achieved.
16 serious adverse events were observed in seven patients treated at the highest dose level. No new safety signals or grade 3 or greater immune-related adverse events were observed.
Dr. Alexander Olawaiye, a professor and one of the gynecologic cancer researchers at UPMC Magee-Womens Hospital and lead investigator of the study, added, "Patients with recurrent gynecologic malignancies who progress following immunotherapy often have limited treatment options. The clinical activity observed with denileukin diftitox-cxdl plus pembrolizumab, including durable responses and prolonged disease control in heavily pre-treated patients, is notable. Given the lack of effective salvage treatments for these patients, especially those that have failed prior immune-checkpoint inhibition, the novel combination of LYMPHIR plus pembrolizumab provides a potential viable therapeutic option. Importantly, the safety profile observed was manageable in this heavily pre-treated population, supporting continued evaluation in larger studies."

Ongoing translational studies are evaluating the impact of the combination on regulatory T-cells, immune effector cells, and the tumor microenvironment to help identify potential biomarkers in order to optimize future development strategies. A Phase 2 expansion study is being planned to further evaluate the combination in gynecologic cancers, including less heavily pre-treated and prior immunotherapy-exposed patient populations.

About the Study

This open‑label, dose‑escalation, investigator‑initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee‑Womens Hospital, enrolled 25 patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21‑day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression. Citius Oncology provided study drug and financial support to the investigator-initiated study; the study was designed, conducted, and analyzed by the UPMC investigators.

Important note on investigational use: The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication of relapsed or refractory Stage I–III cutaneous T-cell lymphoma. LYMPHIR is not approved by the FDA for the treatment of gynecologic malignancies or any solid tumor, and the safety and efficacy of LYMPHIR in this setting have not been established. This Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. Early-stage clinical data may not be predictive of results from larger or later-stage studies.

About Gynecologic Cancers

Recurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new endometrial cancer cases expected in the United States in 20261, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6%) and approximately 20,000 new diagnoses each year in the United States2. These cancers are often detected at advanced stages, and although many patients initially respond to platinum‑based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD‑1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR’s transient depletion of regulatory T‑cells in combination with anti-PD-1 checkpoint inhibition may potentially enhance host anti‑tumor immune responses and help overcome immunotherapy resistance in these difficult‑to‑treat tumors.

About LYMPHIR (denileukin diftitox‑cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl-associated anti-tumor activity is achieved via a direct cytocidal action on IL-2R-expressing tumors and depletion of host immunosuppressive regulatory T lymphocytes (Tregs).

In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, JUN 1, 2026, View Source [SID1234666334])

Biond Biologics and Guangzhou-Israel Biotechnology Fund ("GIBF") Announce Closing of $8 Million Investment and Collaboration

On June 1, 2026 Biond Biologics Ltd., a private clinical-stage biotechnology company developing first-in-class immunotherapies for cancer and immune-mediated diseases, and the Guangzhou-Israel Biotechnology Fund (GIBF), a leading life science investment fund, reported a strategic $8 million investment together with the formation of a China-based joint venture to advance Biond’s innovative oncology pipeline.

The newly established joint venture will focus on accelerating the development of Biond’s lead programs, including BND-67, a first-in-class therapy targeting CD28 shedding, as well as BND-22, a Phase 2 anti-ILT2 antibody and additional pipeline assets. The collaboration is designed to leverage Biond’s differentiated oncology science together with GIBF’s deep expertise in the Chinese biotechnology ecosystem, including clinical development, regulatory strategy, and local collaborations. Through this partnership, Biond and GIBF aim to accelerate clinical execution, expand combination strategies, and maximize the value of Biond’s pipeline within the Chinese market.

Biond’s pipeline

BND-22 is a Phase 2 anti-ILT2 checkpoint inhibitor designed to restore anti-tumor immunity by targeting the ILT2–HLA-G axis. BND-22 has demonstrated efficacy in heavily treated cancer patients in indications that hardly respond to Immuno-Oncology (IO) therapies, such as MSS-CRC, and is currently being evaluated in an ongoing Phase 2 study at MD Anderson Cancer Center.

BND-67 is Biond’s next-generation immunotherapy and a first-in-class asset targeting CD28 shedding, a novel immune evasion mechanism with the potential to redefine T-cell modulation in cancer. Given the central role of CD28 in T-cell activation, BND-67 introduces a fundamentally new approach to restoring immune responsiveness. By preserving CD28 signaling, it enhances effector T-cell activity while selectively inhibiting regulatory T-cell function, driving a potent and sustained anti-tumor response. The program is IND-ready, with a Phase 1 trial planned for Q2 2026.

"Entering this strategic partnership with GIBF marks an important milestone in advancing our pipeline globally," said Ori Shilo, CFO and Co-Founder of Biond Biologics. "By combining our novel scientific approaches with GIBF’s deep understanding of the Chinese biotech landscape, we are well-positioned to accelerate the development of our lead programs, BND-22 and BND-67, and expand their potential across key indications, leveraging both our clinical and business capabilities and the scale of the Chinese market."

"We are pleased to partner with Biond Biologics, a company developing highly differentiated therapies targeting novel immune pathways," said Avner Lushi, Managing Partner of GIBF. "The Chinese biotech market has rapidly evolved into a leading source of innovation, supported by high-quality clinical development and strong translational science. We believe that leveraging GIBF’s unique investment model will enable the efficient advancement of Biond’s assets and create meaningful value for both patients and stakeholders in the coming years. Together with Biond, we are also seeking additional collaborations across Asia to further expand Biond’s capabilities and geographic footprint."

(Press release, Biond Biologics, JUN 1, 2026, View Source [SID1234666333])

SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO

On June 1, 2026 SystImmune, Inc., a clinical-stage biotechnology company, reported the oral presentation of Phase 1 data for BL-M14D1 in patients with small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors (BL-M14D1-101, NCT06505824) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago. BL-M14D1 is a DLL3 targeting antibody drug conjugate being developed globally by SystImmune, a subsidiary of Biokin.

This study evaluated the safety and efficacy of BL-M14D1 in Chinese patients with advanced SCLC, NEC, and other solid tumors. As of the November 30, 2025 data cut-off, BL-M14D1 demonstrated:

Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including SCLC and other NECs
Manageable safety profile, with hematologic adverse events managed with standard supportive care
A total of 127 patients with advanced solid tumors were treated, including 87 with SCLC and 40 with NEC. Most patients were heavily pre-treated. The most common adverse events were hematologic, including neutropenia, which were generally manageable and infrequently led to dose reductions or serious complications. The safety profile is consistent with other brengitecan based topo1 ADCs. One case of grade 3 interstitial lung disease was seen, and one treatment related death was reported.

Among patients with SCLC treated at 4.0 mg/kg D1Q3W, the confirmed objective response rate was 62% (21 of 34 patients), with a median progression-free survival of 7.2 months. Based on these results, SystImmune plans to initiate a global registrational study in first-line extensive-stage SCLC.

"These initial Phase 1 results for BL-M14D1 demonstrate compelling anti-tumor activity, including a 62% confirmed response rate and encouraging durability, in heavily pre-treated patients with small-cell lung cancer," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "Given the significant unmet need in this population, we believe these data support the potential for BL-M14D1 to become an important new treatment option, and we are rapidly advancing the program into global registrational studies in the first-line setting."

About the BL-M14D1-101 Phase I clinical trial

BL-M14D1-101 (NCT06505824) is a multi-center, Phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors. The study is being conducted in three parts (dose escalation, dose finding, and dose expansion) with patients being dosed on Day 1 of a continuous 21-day treatment cycle (D1Q3W). In the dose escalation and dose expansion phase, patients were treated with BL-M14D1 at 0.66, 2.0, 3.5, 4.0, 4.5, 5.0, and 6.0 mg/kg. In the dose expansion phase, SCLC and NEC patients were treated at 4.0 and 4.5mg/kg D1Q3W. The primary endpoint includes safety. Secondary endpoints include objective response rate (ORR) by RECIST 1.1 criteria, duration of response (DoR), disease control rate (DCR), and PK analysis.

About BL-M14D1

SystImmune is advancing a portfolio of next-generation antibody-drug conjugates (ADCs) built on its proprietary brengitecan platform, which utilizes a potent topoisomerase I inhibitor payload designed for targeted delivery to tumor cells. The clinical progress of izalontamab brengitecan (iza-bren) provides initial validation of this platform’s potential to deliver meaningful anti-tumor activity across multiple cancer types.

BL-M14D1 targets DLL3, which is highly expressed in small-cell lung cancer and neuroendocrine tumors, facilitating selective delivery of the brengitecan payload to DLL3-positive tumor cells.

(Press release, SystImmune, JUN 1, 2026, View Source [SID1234666332])