On May 31, 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 therapies to address unmet medical needs in cancer, reported that the Company presented its first dataset of alrizomadlin (APG-115), an MDM2-p53 inhibitor from the Company’s apoptosis-targeted pipeline, as monotherapy or in combination with lisaftoclax (APG-2575) in pediatric patients with relapsed/metastatic rhabdomyosarcoma (RMS) or other soft-tissue sarcomas (STSs), in a rapid oral presentation at the 62nd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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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 largest gathering of the clinical oncology community. This year marks Ascentage Pharma’s ninth consecutive appearance at ASCO (Free ASCO Whitepaper). A total of six studies involving three of the Company’s key assets were selected for presentation, including three rapid oral presentations.

The data presented demonstrated preliminary antitumor activity and a manageable tolerability profile of alrizomadlin in pediatric solid tumors. Results showed that alrizomadlin monotherapy demonstrated initial clinical benefit in pediatric rhabdomyosarcoma (RMS), with one pediatric patient achieving a complete response (CR). In combination with investigational selective Bcl-2 inhibitor lisaftoclax, encouraging antitumor activity was observed, with an objective response rate (ORR) of 23.5% among 17 response-evaluable patients, including one complete response in a patient with Ewing sarcoma and three partial responses (PRs). In terms of safety, alrizomadlin, either as monotherapy or in combination with lisaftoclax, demonstrated a manageable safety profile in pediatric patients with solid tumors.

Alrizomadlin is an orally administered, highly selective MDM2-p53 inhibitor independently developed by Ascentage Pharma. It is the first investigational agent of its class to enter clinical development in China and has global first-in-class potential. By blocking the MDM2-p53 protein-protein interaction, alrizomadlin restores the tumor suppressor activity of p53 and induces apoptosis in tumor cells. Recently, alrizomadlin was officially included by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in the Pilot Program for the Support of Anti-tumor Drugs R&D for Kids, also known as the "SPARK Plan," for development in pediatric solid tumors including neuroblastoma, rhabdomyosarcoma, and Ewing sarcoma.

Professor Yizhuo Zhang, principal investigator of the study from the Department of Pediatric Oncology at Sun Yat-sen University Cancer Center, said: "Relapsed/refractory pediatric sarcomas are associated with extremely poor prognosis and substantial unmet medical needs. The data presented at the ASCO (Free ASCO Whitepaper) meeting demonstrated a favorable tolerability profile and promising anti-tumor effect for alrizomadlin both as monotherapy and in combination with lisaftoclax, with the complete response (CR) cases being particularly encouraging. As a key candidate included in the SPARK Plan, alrizomadlin has the potential to become a first-in-class therapy, address unmet medical needs, and bring new hope for long-term survival to pediatric patients."

Professor Yi Zhang, investigator of the study from the Department of Pediatrics at Beijing Tongren Hospital, Capital Medical University, said: "Treatment options for pediatric solid tumors, especially advanced soft-tissue sarcomas, remain very limited. The clinical data generated by the alrizomadlin combination regimen are therefore particularly meaningful. This apoptosis pathway-targeting therapy demonstrated favorable tolerability and encouraging objective response rates, further supporting the therapeutic potential of dual-target combination approaches in refractory pediatric tumors and providing valuable direction for future precision drug development in pediatric oncology."

Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: "Pediatric solid tumors continue to represent an area of significant unmet medical need. The data presented at ASCO (Free ASCO Whitepaper) mark our first presentation of alrizomadlin clinical data in pediatric solid tumor patients and demonstrated encouraging preliminary clinical benefit and tolerability. Importantly, alrizomadlin has already been included by the CDE in the SPARK Plan for potential development in multiple pediatric solid tumors. The data presented provide initial clinical evidence supporting this development strategy. We will continue to advance the related clinical studies with the goal of bringing new treatment options to pediatric patients in urgent need."

Key highlights from the study presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:

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
Presentation Type: Rapid Oral Presentation
Session Title: Pediatric Oncology II
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
Key Highlights:

Research Background: This multicenter clinical trial conducted in China evaluated the safety and preliminary efficacy of alrizomadlin (APG-115) as monotherapy or in combination with lisaftoclax in heavily pretreated pediatric patients with relapsed/metastatic RMS, Ewing sarcoma (EWS), neuroblastoma (NB), and other solid tumors.
Efficacy Data: In the monotherapy arm, 1 patient with refractory RMS achieved CR. In the combination arm, among 17 response-evaluable pediatric patients with relapsed/refractory solid tumors, the ORR was 23.5%, including 1 CR in a patient with EWS, as well as PRs in 2 patients with RMS and 1 patient with NB. The disease control rate (DCR) was 70.6%.
Safety Data: No dose-limiting toxicities (DLTs) were observed in either the monotherapy or combination arm. Adverse events were primarily gastrointestinal and hematologic, with few serious adverse events and no treatment-related deaths or discontinuations.
Conclusion: The regimen demonstrated a manageable safety profile and preliminary antitumor activity in pediatric solid tumors, supporting further investigation.

* Alrizomadlin is currently under investigation and has not yet been approved by the US FDA.

(Press release, Ascentage Pharma, MAY 31, 2026, View Source [SID1234666283])

On May 31, 2026 Servier reported updated efficacy and safety results from more than three years of follow-up in the Phase 3 INDIGO trial evaluating VORANIGO (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (IDH1/2) glioma following surgical intervention and who are not in immediate need of chemoradiotherapy. These data, which will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 at 4:36 p.m. CDT in Chicago, strengthen the previous findings from the INDIGO pivotal trial and demonstrate the clinical benefits of VORANIGO continue to improve over time.

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The extended analysis includes 21.3 months of additional unblinded data collected between the March 7, 2023, trial unblinding and the January 17, 2025, data cutoff. As of data cutoff, all 163 patients enrolled in the placebo arm discontinued treatment and 144 crossed over to the VORANIGO treatment arm. Median follow-up was 41.6 months. These results build upon the placebo-controlled, double-blind data previously published in The Lancet Oncology.

"The extended Phase 3 INDIGO trial analysis significantly improves our understanding of the clinical benefits of VORANIGO," said Islam Hassan, M.D., MSc., Global Head of Development-Neuro-Oncology at Servier. "With more than three years of follow-up data, these results validate the durable and sustained benefits of long-term treatment with VORANIGO and demonstrate a steady improvement in patient responses over time. We are proud to share these results and remain committed to expanding our understanding of the long-term impact of VORANIGO for the glioma community."

A global, randomized, double-blinded, Phase 3 trial of vorasidenib vs placebo in patients with grade 2 glioma with an IDH1/2 mutation (INDIGO): updated efficacy and safety – Sunday, May 31, 4:36 – 4:42 p.m. CDT

Key findings, which were presented by Timothy Cloughesy, M.D., David Geffen School of Medicine, Department of Neurology, University of California, Los Angeles, an investigator for the INDIGO trial, include:

Median progression-free survival (PFS) per blinded independent review committee (BIRC) was 44.1 months (95% CI, 27.7-not estimable [NE]) in patients treated with VORANIGO. PFS was the primary endpoint of the trial.
The median time to next intervention (TTNI) per BIRC for patients treated with VORANIGO was NE (95% CI, 52-NE). The number of next-intervention events remained low among VORANIGO patients (23.8%), indicating that VORANIGO is effectively delaying the need for subsequent treatment. TTNI was a key secondary endpoint of the trial.
Patients treated with VORANIGO experienced an objective response rate (ORR) per BIRC of 20.8% (95% CI, 15%-27.8%). ORR improved with longer follow-up, reflecting durable and gradual responses with VORANIGO. An additional 72.6% of patients experienced stable disease.
Median duration of treatment among VORANIGO patients was 38.3 months (95% CI, 19.98-43.76).
A 72% reduction in the rate of on-treatment seizures was observed in patients treated with VORANIGO.
The safety profile of VORANIGO was tolerable with mainly low-grade adverse events (AEs) and consistent with previously reported data. The most commonly reported Grade ≥3 or worse treatment-emergent adverse events (TEAEs) were increased alanine aminotransferase (10.8%), increased aspartate aminotransferase (4.8%), seizures (4.8%), increased gamma-glutamyltransferase (3%) and syncope (1.8%). No new safety signals were detected and fewer than 5% of patients discontinued treatment due to an AE. There were no treatment-related deaths.
"Historically, many patients with Grade 2 IDH-mutant gliomas faced a poor long-term prognosis and managed their disease with a ‘watch and wait’ strategy due to the limited availability of targeted treatment options," said Dr. Timothy Cloughesy. "The latest results from the Phase 3 INDIGO trial—the largest dataset in IDH-mutant glioma to date—provide valuable evidence on how long-term IDH inhibition can delay disease progression and extend the time to next intervention."

Impact of vorasidenib vs placebo on seizure rates and quality of life: exploratory analysis from Phase 3 INDIGO study – Monday, June 1, 1:30 – 4:30 p.m. CDT

Findings from an exploratory analysis of the INDIGO study evaluating the impact of VORANIGO on seizure rates and quality of life will be shared in a separate presentation. As of data cut off in January 2025, results show:

The rate of seizures per person per year in the VORANIGO arm (15.9 seizures per person-year [95% CI, 9.1-27.7]; p=0.0002) demonstrated the sustained, positive, long-term effect of VORANIGO on seizure control.
The effects of VORANIGO were more pronounced among people with oligodendrogliomas (6.9 seizures per person-year [95% CI, 2.7-17.7]; p<0.0001) than those with astrocytoma (17.5 seizures per person-year [95% CI, 9.4-32.3]; p=0.6448).
VORANIGO had an acceptable safety profile with no new safety signals during extended follow-up.

(Press release, Servier, MAY 31, 2026, View Source [SID1234666268])

On May 31, 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 updated efficacy and safety data from a clinical study of its first approved product, olverembatinib (HQP1351), as a second-line therapy in patients with chronic-phase chronic myeloid leukemia (CML-CP) were presented in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s most prominent scientific gathering in the clinical oncology community, showcasing cutting-edge research in clinical oncology and advanced cancer therapies. This year marks Ascentage Pharma’s ninth consecutive appearance at the ASCO (Free ASCO Whitepaper) Annual Meeting. A total of six studies involving three of the Company’s key assets were selected for presentation, including three rapid oral presentations.

Data presented in this rapid oral presentation showed that, at cycle 24, patients with CML-CP treated with olverembatinib achieved a complete cytogenetic response (CCyR) rate of 91.3% and a major molecular response (MMR) rate of 60.9%. Responses deepened over time with longer treatment duration. Olverembatinib demonstrated a stable and manageable safety profile during long-term treatment, with no new safety signals identified. This longer follow-up study has generated more mature and encouraging results, further supporting the efficacy and safety of olverembatinib in patients with CML without the T315I mutation and reinforcing its potential role as a second-line treatment option for patients with CML-CP that failed first-line TKI therapy.

Olverembatinib is a novel drug developed by Ascentage Pharma and represents the first third-generation BCR-ABL1 inhibitor approved in China. Olverembatinib is currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. The drug is currently approved in China for adult patients with tyrosine kinase inhibitor (TKI)-resistant CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs, with all approved indications now covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III studies to evaluate olverembatinib in multiple indications, including CML-CP, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), with two of these studies having been cleared by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Ascentage Pharma has signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.

Professor Weiming Li, the Principal Investigator of this study from Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, stated: "Overall, with longer treatment duration, olverembatinib not only helped patients achieve deeper responses, but also continued to provide durable clinical benefit while maintaining a favorable safety and tolerability profile, resulting in good patient adherence. These findings further support its role as a potential second-line treatment option for patients with CP-CML without the T315I mutation and provide stronger evidence for clinical practice. We also look forward to additional long-term follow-up data to further validate its efficacy and safety, and to provide stronger evidence-based support for the standardized use and guideline recommendations of olverembatinib in the second-line treatment setting, helping to deliver more optimized treatment options for patients and clinicians."

Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: "The updated data presented at ASCO (Free ASCO Whitepaper) once again demonstrated the consistent performance of olverembatinib in the second-line treatment of CML, further strengthening our confidence in advancing this therapy into earlier lines of treatment. We look forward to continuously accumulating evidence from second-line and earlier-line settings to further optimize the treatment pathway for patients with CML and help to deliver greater clinical benefit, longer survival, and improved quality of life. Moving forward, we will continue to uphold our mission of addressing unmet clinical needs for patients around the world by accelerating clinical development and bringing more safe and effective therapies to patients as soon as possible."

Key highlights from the study presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:
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
First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Key Highlights:

Research Background: This is a single-arm, multicenter, open-label study conducted in China, evaluating the efficacy and safety of olverembatinib as a second-line treatment.
Efficacy Data: Among 42 evaluable patients, olverembatinib demonstrated significant and progressively deepening anti-tumor activity, with a best CCyR rate of 76.2% and a best MMR rate of 47.6% at study cutoff. Responses continued to improve with longer treatment duration, reaching 91.3% and 60.9%, respectively, at cycle 24. High response rates were also observed in patients previously treated with second-generation TKIs.
Safety Data: In terms of safety, the overall incidence of treatment-related adverse events was 89.4%, most of which were manageable low-grade events, primarily including but not limited to skin hyperpigmentation, hyperuricemia, and increased creatine phosphokinase. Although some grade ≥3 hematologic toxicities were observed, they were all recoverable through supportive treatment.
Conclusion: Overall, olverembatinib demonstrated durable and progressively deepening efficacy while maintaining a manageable safety profile, highlighting its promising clinical potential.
* Olverembatinib is currently under investigation and has not yet been approved by the US FDA.

(Press release, Ascentage Pharma, MAY 31, 2026, View Source [SID1234666284])

On May 31, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

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Key findings are detailed below.

Oral Presentation: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; Date/Time: May 31, 2026, 9:12 AM CDT; Location: Arie Crown Theater; Abstract: 2504; Presenter: Joseph Sacco, PhD, MBChB

The Phase 1 first-in-human trial enrolled 85 heavily pretreated patients with advanced solid tumors, including uveal melanoma, colorectal cancer, head and neck cancers, pancreatic cancer, cutaneous melanoma, and sarcoma.
Patients had received a median of 2 prior lines of systemic therapy; 42% had received prior immune checkpoint inhibitor (ICI) therapy
RP2 monotherapy achieved an objective response rate (ORR) of 19.0% (4/21 evaluable patients), with responses observed in uveal melanoma, esophagogastric adenocarcinoma, chordoma, and mucoepidermoid carcinoma
RP2 in combination with nivolumab achieved an ORR of 19.1% (9/47 evaluable patients), with a disease control rate of 48.9%
In uveal melanoma, where a randomized Phase 2/3 trial is enrolling, the pooled ORR (RP2 in combination with nivolumab and RP2 monotherapy) was 33.3%
Responses were durable: median duration of response was not reached in the monotherapy group (range: 11.5–27.3+ months) and was 22.1 months in the combination group (range: 2.8–35.2+ months)
Tumor regression was observed in both injected and non-injected lesions, including in all 3 monotherapy responders who had non-injected lesions, demonstrating a systemic immune response beyond the site of injection
Translational analyses demonstrated that RP2 reprogrammed tumors from immunologically "cold" to immune-inflamed, upregulated T-cell cytotoxicity and antigen presentation pathways, and significantly expanded HSV-1-specific and tumor-associated (MAGE) TCR clones, confirming the intended mechanism of action and systemic immune engagement.
RP2 monotherapy and RP2 in combination with nivolumab were well tolerated with no unexpected toxicities, no Grade 4 or 5 treatment-related adverse events, and no increase in immune-related adverse events beyond the expected profile of nivolumab alone; the most common events were low-grade pyrexia, chills, and fatigue, consistent with systemic immune activation
Based on these results, RP2 is being evaluated in combination with nivolumab in patients with metastatic uveal melanoma in a randomized Phase 2/3 trial (NCT06581406)
About RP2
RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, MAY 31, 2026, View Source [SID1234666251])

On May 31, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that ivonescimab, the Company’s first-in-class PD-1/VEGF bispecific antibody, has achieved a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment for patients with advanced squamous non-small cell lung cancer (sq-NSCLC) in the Phase III HARMONi-6 (AK112-306) study. These landmark findings will be featured in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Professor Shun Lu, Director of the Lung Cancer Center at Shanghai Chest Hospital and Principal Investigator of HARMONi-6, presented the data in an oral Plenary Session presentation.

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This marks the first time a China-originated investigational oncology drug has been selected for the ASCO (Free ASCO Whitepaper) Plenary Session in the society’s 61-year history. This moment is a definitive testament to the ivonescimab regimen’s role in ushering cancer immunotherapy into the ‘2.0 Era’.

The HARMONi-6 study results were simultaneously published in The Lancet.

The HARMONi-6 study enrolled a total of 532 patients. Among them, approximately 63% had centrally located squamous tumors, 39.0% had PD-L1 TPS <1%, and 33.8% had multi-site metastases, liver metastases, or brain metastases. At the pre-specified interim analysis, as assessed by the Independent Data Monitoring Committee (IDMC), the study met its key secondary endpoint of overall survival (OS), demonstrating both clinically a meaningful and statistically significant benefit.

As of the data cutoff date of February 27, 2026, with a median follow-up of 21.36 months:

34% reduction in the risk of death – ivonescimab plus chemotherapy significantly prolonged OS

In the intent-to-treat (ITT) population, ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy (HR=0.66 [95% CI: 0.50–0.87], P=0.0017(＜0.0049). Median OS was 27.9 months in the ivonescimab arm (the final death event in this arm caused the Kaplan-Meier curve to drop sharply to the median, thereby producing the mOS estimate) versus 23.7 months in the control arm.
The 12-month OS rate was 78.9% with ivonescimab plus chemotherapy versus 72.2% in the control arm, and the 24-month OS rate was 64.7% versus 48.6%, respectively. The survival benefit continued to widen over time, reflecting a more durable and clinically meaningful long-term survival advantage.
Consistent OS benefit across all prespecified subgroups

OS benefit with ivonescimab was observed consistently regardless of PD-L1 expression status: HR=0.68 in the PD-L1 TPS ≥1% subgroup and HR=0.64 in the TPS <1% subgroup; HR=0.67 in the PD-L1 TPS 1–49% subgroup and HR=0.64 in the TPS ≥50% subgroup.
The OS benefit was also consistent across subgroups defined by metastatic burden: HR=0.47 in patients with ≥3 metastatic sites and HR=0.69 in those with liver metastases.
Comparable subsequent anticancer therapy between the two arms

Proportions of patients in the two groups who subsequently received immunotherapy: 13.9% in the treatment group vs 19.2% in the control group; proportions receiving targeted therapy: 12.4% vs 17.3%; proportions receiving ADC therapy: 4.5% vs 5.6%; proportions participating in other clinical trials: 0.8% vs 2.3%.

Favorable safety profile comparable to tislelizumab plus chemotherapy

Grade ≥3 treatment-related adverse events (TRAEs) occurred in 69.2% of patients in the ivonescimab arm and 58.9% in the control arm.
Rates of adverse events leading to treatment discontinuation or death were similar between arms.
At the prespecified interim analysis for progression-free survival (PFS), ivonescimab plus chemotherapy had already demonstrated a clinically meaningful and statistically significant improvement in PFS compared with tislelizumab plus chemotherapy, with a median PFS of 11.1 months versus 6.9 months (HR=0.60 [95% CI: 0.46–0.78], P＜0.0001).

Professor Shun Lu, Principal Investigator of HARMONi-6, Director of the Lung Cancer Center at Shanghai Chest Hospital and Tenured Professor:

"HARMONi-6 is the first global Phase III study in lung cancer to show statistically significant improvements in both OS and PFS compared with PD-1 plus chemotherapy. It is also the first in sq-NSCLC to achieve dual OS and PFS success through a pre-specified hypothesis test. The results significantly reduced the risk of death and disease progression, with consistent benefits across all subgroups, while enabling patients to maintain better quality of life for longer.

These strong head-to-head data redefine the gold standard for first-line sq-NSCLC treatment and fill a major clinical gap for anti-angiogenic therapy in this setting. We look forward to ivonescimab delivering broader benefits to patients worldwide as a next-generation immuno-oncology therapy."

Dr. Yu Xia, Founder, Chairwoman, President and CEO of Akeso:

"Today, we are thrilled to announce that ivonescimab plus chemotherapy has successfully challenged PD-1 plus chemotherapy, achieving both clinically meaningful and statistically significant improvements in overall survival (OS) and progression-free survival (PFS). We extend our sincere gratitude to all investigators, clinical teams, and patients who participated in this study. Thanks to their efforts, Chinese patients with advanced sq-NSCLC are the first to benefit from this innovative, safe, and highly effective global therapy.

Prior to ivonescimab, no therapy had successfully challenged the dominance of PD-1-based regimens in a head-to-head Phase III trial. Ivonescimab has already demonstrated dual OS and PFS benefits in EGFR-mutant non-squamous NSCLC after TKI failure, becoming the first immunotherapy approved in this setting. It has also shown superior PFS versus pembrolizumab monotherapy in first-line PD-L1-positive NSCLC. These results have generated strong global anticipation for next-generation therapies. Since its launch, ivonescimab has been widely adopted by clinicians and patients.

PD-1 plus chemotherapy is currently the most broadly used first-line regimen in oncology. Following our previous success versus pembrolizumab monotherapy, the HARMONi-6 study now demonstrates for the first time that ivonescimab plus chemotherapy can achieve dual superiority in both OS and PFS over PD-1 plus chemotherapy. This landmark result solidifies ivonescimab’s position as a next-generation cornerstone of cancer immunotherapy.

The success of HARMONi-6 gives us even greater confidence to leverage global resources, fully unlock ivonescimab’s potential, reshape treatment paradigms, and deliver more effective and safer solutions to patients worldwide."

Ivonescimab is currently being evaluated in more than 30 clinical settings across a wide range of tumors, including 15 Phase III trials, seven of which are head-to-head studies versus PD-1/PD-L1 therapies. The positive results from HARMONi-6 further strengthen its differentiated clinical profile. In partnership with Summit Therapeutics, Akeso remains fully committed to advancing the global development of ivonescimab to maximize its therapeutic benefit for patients worldwide.

(Press release, Akeso Biopharma, MAY 31, 2026, View Source [SID1234666269])