On April 21, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported that it will present new data from its pivotal Phase 3 ROSELLA trial of Lifyorli (relacorilant) plus nab-paclitaxel in platinum-resistant ovarian cancer at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data will be presented in an oral presentation on Friday, May 29, 2026.

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Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72, APGOT-Ov10, LACOG-0223, and ANZGOG-2221/2023)

Oral Abstract Session – Gynecologic Cancer
May 29, 2026, 2:45 PM – 5:45 PM CDT
Abstract Number: 5503
Lifyorli, in combination with nab-paclitaxel, was approved by the U.S. Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA). It is included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen for patients with platinum-resistant ovarian cancer.

The ROSELLA trial was conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Lifyorli

Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement to receive Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.

It is included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen for patients with platinum-resistant ovarian cancer.

Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support at 1-85-LIFYORLI (1-855-439-6754).

LIFYORLI Indication & Usage

LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.

IMPORTANT SAFETY INFORMATION

Contraindications:

LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.

Warnings and Precautions:

Neutropenia and Severe Infections

LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.

Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.

Adrenal Insufficiency

LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.

Exacerbation of Conditions Treated with Glucocorticoids

Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.

Embryo-Fetal Toxicity

LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.

Adverse Reactions:

Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).

Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.

The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Drug Interactions:

Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.
Use in Specific Populations:

Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose.
Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.
Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).

(Press release, Corcept Therapeutics, APR 21, 2026, https://ir.corcept.com/news-releases/news-release-details/corcept-present-new-data-pivotal-phase-3-rosella-trial [SID1234664605])

On April 21, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported updated clinical data from two Phase 1/2 trials of daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). Data from the daraxonrasib combination cohort will be presented in a late-breaking mini-symposium, and data from the monotherapy cohort will be presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 21, 2026.

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Findings from both trials support daraxonrasib’s continued evaluation in the first line setting, demonstrating manageable safety and tolerability profiles along with early signs of durable antitumor activity across monotherapy and combination approaches.

"Patients with metastatic pancreatic cancer continue to face challenging outcomes," said Eileen M. O’Reilly, M.D., Winthrop Rockefeller Endowed Chair of Medical Oncology at Memorial Sloan Kettering Cancer Center, and a key investigator for the RMC-6236-001 trial. "What I find notable about these datasets is the strength of antitumor activity observed with daraxonrasib across both monotherapy and combination therapy, along with manageable safety profiles. With longer follow up, these results further support the potential of a novel RAS-targeted therapy to meaningfully improve outcomes in frontline metastatic PDAC."

"The activity observed with daraxonrasib in the first line setting, as both single-agent and combination therapy, represents a promising signal in this difficult-to-treat population," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "We believe these findings support continued evaluation of daraxonrasib in the ongoing Phase 3 RASolute 303 trial in patients with previously untreated metastatic PDAC."

Daraxonrasib plus Chemotherapy as First Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma (Abstract #LB407)

RMC-GI-102 (NCT06445062) is a Phase 1/2 open-label, multicenter trial with multiple cohorts evaluating daraxonrasib-based combinations in patients with RAS mutant gastrointestinal tumors. The results to be presented at the AACR (Free AACR Whitepaper) Annual Meeting focus on patients in the first line metastatic PDAC cohort treated with daraxonrasib plus gemcitabine and nab-paclitaxel (GnP).

As of a December 1, 2025 data cutoff, 40 patients with previously untreated RAS mutant metastatic PDAC received daraxonrasib 200 mg once daily in 28-day cycles plus GnP given on a Day 1 and Day 15 schedule. In these patients, daraxonrasib plus GnP had a manageable safety profile, and the safety profile observed for the combination regimen was consistent with the known safety findings of each respective agent. The most common Grade ≥3 treatment-related adverse events (TRAEs) were anemia (33%), decreased neutrophil count (20%), and fatigue (18%). No Grade 5 TRAEs were reported. In the trial, TRAEs led to discontinuation of daraxonrasib in 5% (n=2) of patients and of GnP in 15% (n=6) of patients. The mean dose intensity was 82% for daraxonrasib and 80% for GnP.

Daraxonrasib plus GnP showed encouraging preliminary antitumor activity in patients with previously untreated RAS mutant metastatic PDAC. In patients who had at least 18 weeks of follow up prior to the data cutoff (n=40), the confirmed objective response rate (ORR) was 58% (95% confidence interval (CI): 41, 73), including one complete response. Median progression-free survival (PFS) and median overall survival (OS) were not mature at the data cutoff. The Kaplan-Meier estimate for PFS at 6 months was 84% (95% CI: 68, 93) and for OS was 90% (95% CI: 76, 96).

Daraxonrasib Monotherapy as First Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma (Abstract #LB337)

RMC-6236-001 (NCT05379985) is a Phase 1/2 open-label, multicenter trial evaluating daraxonrasib monotherapy in patients with RAS mutant solid tumors.

As of a December 1, 2025 data cutoff, patients with previously untreated RAS mutant metastatic PDAC received daraxonrasib 300 mg daily in 21-day cycles. In these patients, the safety profile observed for daraxonrasib was generally consistent with the reported safety findings for daraxonrasib monotherapy in previously treated patients. All-grade TRAEs occurred in 95% (n=38) of patients and Grade ≥3 TRAEs occurred in 38% (n=15) of patients. The most common Grade ≥3 TRAEs reported in at least 10% of patients were rash, diarrhea, and stomatitis. No Grade 4 or 5 TRAEs were reported. The mean dose intensity was 84%.

Daraxonrasib demonstrated encouraging preliminary antitumor activity in patients with previously untreated RAS mutant metastatic PDAC, with an ORR of 47% (95% CI: 31, 64), including one complete response, and a disease control rate of 92% (95% CI: 79, 98). Median PFS and median OS data were not yet mature at the data cutoff. The Kaplan-Meier estimate for PFS at 6 months was 71% (95% CI: 53, 83) and for OS was 83% (95% CI: 67, 92).

Daraxonrasib is being evaluated in four global Phase 3 clinical trials: three in PDAC (two ongoing and one completed) and one in non-small cell lung cancer (NSCLC). The company recently announced that the pivotal Phase 3 RASolute 302 clinical trial in patients with previously treated metastatic pancreatic cancer met all primary and key secondary endpoints, including PFS and OS. In the trial, daraxonrasib demonstrated an unprecedented OS benefit in all enrolled patients (the intent to treat population), including those with tumors with and without (wild type) an identified RAS mutation.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.3,4

About Daraxonrasib

Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a broad range of cancers driven by oncogenic RAS, including PDAC, NSCLC and colorectal cancer. Daraxonrasib suppresses RAS signaling by blocking the interaction of wild-type and mutant RAS(ON) with its downstream effectors.

(Press release, Revolution Medicines, APR 21, 2026, View Source [SID1234664621])

On April 21, 2026 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported they have been selected for a late-breaking abstract (LBA) oral presentation to provide the complete data from the Phase 2/3 registrational trial (OptimUM-02) of darovasertib in combination with crizotinib in first-line (1L) HLA*A2-negative metastatic uveal melanoma at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on May 29-June 2 in Chicago, Illinois. The presentation will include detail and additional data from OptimUM-02 that were not disclosed with the company’s topline release.

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Presentation details

Late-Breaking Abstract Number: LBA9503

Date and Time: June 1, 2026, 8-11AM CDT, Oral Abstract Session, Melanoma/Skin Cancers

Title: Darovasertib Plus Crizotinib vs Investigator’s Choice as First-Line Treatment for Patients with HLA-A2 Negative Metastatic Uveal Melanoma: Primary Results from the OptimUM-02 trial

Presenter: Dr. Marlana Orloff, M.D., Associate Professor of Medical Oncology, Thomas Jefferson University Hospital

(Press release, Ideaya Biosciences, APR 21, 2026, View Source [SID1234664637])

On April 21, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that six abstracts from clinical studies of three key drug candidates have been selected for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in person at McCormick Place in Chicago, IL, and online, May 29 – June 2, 2026. With three abstracts selected for rapid oral presentations and three abstracts selected for poster presentations, these data highlight the global innovation and clinical value of Ascentage Pharma’s portfolio, inclusive of Olverembatinib (HQP1351), the first third-generation BCR-ABL inhibitor approved in China; Lisaftoclax (APG-2575), the first approved China-developed Bcl-2 selective inhibitor; and Alrizomadlin (APG-115), an MDM2-p53 inhibitor.

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The ASCO (Free ASCO Whitepaper) Annual Meeting showcases cutting-edge research in clinical oncology and advanced cancer therapies and is the world’s most prominent scientific gathering in the oncology community.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "This marks Ascentage Pharma’s ninth consecutive year presenting at the ASCO (Free ASCO Whitepaper) Annual Meeting. We are pleased to once again present our global innovation and R&D capabilities on this premier international stage. The selection of data from multiple studies this year, including three rapid oral presentations, further underscores the global scientific community’s recognition of the clinical value of our drug candidates. We look forward to sharing comprehensive data during the meeting and continuing to accelerate our global clinical development programs, with the goal of bringing more treatment options to patients as soon as possible."

The clinical studies to be presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:

Rapid oral presentations
Olverembatinib (HQP1351) combined with blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL)

Abstract #: 6513
Format: Rapid oral presentation
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: May 30, 2026, 1:15 – 2:45 p.m., Central Time (May 31, 2026, 2:15 – 3:45 a.m., Beijing Time)
First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
Updated efficacy and safety of Olverembatinib (HQP1351) as second-line therapy in patients with chronic-phase chronic myeloid leukemia (CP-CML)

Abstract #: 6510
Format: Rapid oral presentation
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: May 30, 2026, 1:15 – 2:45 p.m., Central Time (May 31, 2026, 2:15 – 3:45 a.m., Beijing Time)
First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Alrizomadlin (APG-115) alone or in combination with lisaftoclax (APG-2575) for the treatment of pediatric patients with relapsed/metastatic rhabdomyosarcoma (RMS) or other soft-tissue sarcomas (STSs)

Abstract #: 10012
Format: Rapid oral presentation
Session Title: Pediatric Oncology II
Date and Time: May 30, 2026, 8:00 – 9:30 a.m., Central Time (May 30, 2026, 9:00 -10:30 p.m., Beijing Time)
First Author: Yizhuo Zhang, MD, Department of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
Poster Presentations
Updated clinical and translational results of Olverembatinib (HQP1351) in patients with succinate dehydrogenase (SDH)-deficient tumors

Abstract #: 11539
Format: Poster presentation
Session Title: Sarcoma
Date and Time: June 1, 2026, 1:30 – 4:30 p.m., Central Time (June 2, 2026, 2:30 – 5:30 a.m., Beijing Time)
First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China
A phase 3 study of Olverembatinib (HQP1351) in patients with chronic-phase chronic myeloid leukemia: POLARIS-2 trial in progress

Abstract #: TPS6608
Format: Poster presentation
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: June 1, 2026, 9:00 a.m. – 12:00 p.m., Central Time (June 1, 2026, 10:00 p.m. -Tuesday June 2, 2026, 1:00 a.m., Beijing Time)
First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
A global multicenter, open-label, randomized, phase 3 registrational study of Lisaftoclax (APG-2575) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): GLORA trial in progress

Abstract #: TPS7101
Format: Poster presentation
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date and Time: June 1, 2026, 9:00 a.m. – 12:00 p.m., Central Time (June 1, 2026, 10:00 p.m. -Tuesday June 2, 2026, 1:00 a.m., Beijing Time)
First Author: Matthew Steven Davids, MD, Dana-Farber Cancer Institute
* Olverembatinib, Lisaftoclax and Alrizomadlin are currently under investigation and have not yet been approved by the FDA in the US.

(Press release, Ascentage Pharma, APR 21, 2026, View Source [SID1234664653])

On April 21, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the first patient has been successfully dosed in a phase Ⅱ clinical study evaluating Opamtistomig (LBL-024), the company’s core investigational PD-L1/4-1BB bispecific antibody, for the first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

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Early symptoms of gastric cancer are often subtle and easily overlooked, leading to most patients being diagnosed at an advanced stage and facing a generally poor prognosis. PD-1 antibody combined with chemotherapy is recommended as the first-line treatment for advanced disease, with median progression-free survival (PFS) at only 7 months and median overall survival (OS) ranging from 13 to 17 months. Crucially, for patients with Combined Positive Score (CPS) <5, immunotherapy demonstrates no statistically significant benefit. These limitations highlight the urgent need to optimize and enhance treatment strategies.

Opamtistomig is a uniquely engineered bispecific antibody designed to simultaneously block PD-1/L1-mediated immune suppression and selectively activate the 4-1BB co-stimulatory pathway. By restoring T-cell functionality and expanding effector T-cell populations within the tumor microenvironment, Opamtistomig has the potential to deliver more potent and durable anti-tumor activity than PD-1/PD-L1 blockade alone, particularly in difficult-to-treat and immunotherapy-resistant tumors. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

The open-label, multi-center Phase Ⅱ clinical study is led by Professor Shen Lin of Beijing Cancer Hospital and is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The current standard of care—PD-1 inhibitors combined with chemotherapy—provides limited clinical benefit despite being recommended as first-line therapy. With a five-year OS rate of merely 9%, advanced gastric cancer demands transformative solutions. Opamtistomig’s Phase Ⅱ trial is strategically designed to leverage its dual-mechanism synergistic enhancement, positioning it to overcome current treatment limitations and establish a new therapeutic paradigm."

About Gastric Cancer
According to data published in 2022 by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were approximately 968,000 new cases and 660,000 deaths from gastric cancer worldwide, making it the fifth most common cancer and the fourth leading cause of cancer mortality globally. China is a high‑incidence country for gastric cancer, with 359,000 new cases (37.1% of global incidence) and 260,000 deaths (39.4% of global mortality) each year, far exceeding global averages. Because early‑stage gastric cancer usually lacks obvious symptoms, only about 20% of cases in China are diagnosed early; the majority are already advanced at diagnosis, resulting in poor overall prognosis and a five‑year survival rate of only around 9%.

About Opamtistomig (LBL-024)
Opamtistomig (LBL-024) is a potential first-in-class bispecific antibody that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, and it holds promise to become the first approved therapy specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC)—a rare malignancy with substantial unmet clinical need.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig features a 2:2 molecular format, incorporating two binding domains each for PD-L1 and 4-1BB with an optimized affinity ratio. This unique design enables dual functionality: reversing PD-L1–mediated immune suppression while selectively enhancing T-cell activation, resulting in a potent and synergistic anti-tumor immune response.

In two ongoing clinical studies in China, Opamtistomig has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. Given the absence of a globally accepted standard of care for EP-NEC, these results support the advancement of a single-arm pivotal study toward potential accelerated approval.

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.

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. Beyond EP-NEC, Opamtistomig has received clinical trial approvals across multiple tumor types with high unmet medical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical activity has already been observed in NSCLC, SCLC, BTC, OC, and other indications, underscoring Opamtistomig’s potential as a broad-spectrum immuno-oncology therapy.

(Press release, Nanjing Leads Biolabs, APR 21, 2026, View Source [SID1234664669])