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First Dual-Positive Immunotherapy with PFS and OS Benefit in EGFR+ NSCLC After EGFR-TKI Progression: Ivonescimab Final OS Analysis from HARMONi-A to Be Presented at SITC 2025

On October 30, 2025 Akeso (9926.HK) reported that the significant results from the final overall survival analysis of the Phase III HARMONi-A study, which evaluates the first-in-class bispecific antibody ivonescimab (PD-1/VEGF bispecific antibody) combined with chemotherapy for EGFR-mutated, non-squamous non-small cell lung cancer (NSCLC) patients after EGFR-TKI progression, have been selected as a Late-Breaking Abstract at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (2025 SITC (Free SITC Whitepaper)).

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Title: Final Overall Survival Analysis of HARMONi-A Study Comparing Ivonescimab Plus Chemotherapy to Chemotherapy Alone in Patients With EGFR+ NSCLC Progressed on EGFR-TKI Treatment

Abstract Number: 1348
Session: Clinical Oral Abstract Session 104
Date/Time: Friday, November 7, 2025, 11:30 AM ET
The HARMONi-A study is the first Phase III trial of an immunotherapy for EGFR-TKI-resistant, EGFR-mutated non-squamous NSCLC to show statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS). This marks ivonescimab’s first final OS analysis in a Phase III trial and confirms its groundbreaking survival benefit for non-squamous NSCLC patients that progressed after EGFR-TKI therapy.

Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, Akeso announced that ivonescimab was successfully added to China’s National Reimbursement Drug List, effective January 1, 2025, ensuring widespread patient access to this life-saving treatment.

Additionally, Akeso’s global partner, Summit Therapeutics, announced in October 2025 that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, seeking approval for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant, third-generation EGFR-TKI-resistant, non-squamous NSCLC.

(Press release, Akeso Biopharma, OCT 30, 2025, View Source [SID1234657174])

Nektar Therapeutics to Participate in the Jefferies Global Healthcare Conference in London

On October 30, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported that company management will be webcasting its participation in the Jefferies Global Healthcare Conference being held November 17-20, 2025 in London.

Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025 – webcast to be available at 11:00 a.m. Greenwich Mean Time / 3:00 a.m. Pacific Time – link here
The fireside chat will be accessible via the webcast link above as well as on the Investor Events section of the Nektar website: View Source A replay of the presentation will be available for 30 days.

If you would like to request a one-on-one meeting with company management during the conference, please reach out to your Jefferies representative.

(Press release, Nektar Therapeutics, OCT 30, 2025, View Source [SID1234657173])

DESTINY-Lung06 Phase 3 Trial of ENHERTU® Initiated as FirstLine Therapy in Patients with HER2 Overexpressing Metastatic NonSquamous Non-Small Cell Lung Cancer

On October 30, 2025 Daiichi Sankyo reported the first patient has been dosed in the DESTINYLung06 phase 3 trial evaluating ENHERTU (trastuzumab deruxtecan) plus pembrolizumab versus pembrolizumab, platinum-based chemotherapy and pemetrexed as a first-line treatment in patients with unresectable, locally advanced or metastatic HER2 overexpressing and PD-L1 TPS <50% non-squamous non-small cell lung cancer (NSCLC).

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

One of the current recommended first-line treatments for patients with HER2 overexpressing metastatic nonsquamous NSCLC is pembrolizumab plus platinum-based chemotherapy and pemetrexed. 1,2,3 Improved outcomes for immunotherapy-based treatments correlate with higher PD-L1 levels, underscoring the need for more targeted treatment options for patients with PD-L1 TPS <50%. 4 There currently are no HER2 directed medicines approved in the first-line setting of metastatic NSCLC.

"DESTINY-Lung06 is evaluating a targeted treatment strategy for patients with HER2 overexpressing metastatic non-squamous non-small cell lung cancer with low PD-L1 expression," said Abderrahmane Laadem, MD, Head, Late-Stage Oncology Clinical Development, Daiichi Sankyo. "In the trial, we are evaluating whether replacing traditional chemotherapy with ENHERTU and combining it with standard of care immunotherapy could potentially improve outcomes for patients in the first-line metastatic setting."

About DESTINY-Lung06

DESTINY-Lung06 is a multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in combination with pembrolizumab versus pembrolizumab, platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed as a first-line treatment in patients with unresectable, locally advanced or metastatic HER2 overexpressing and PD-L1 TPS <50% non-squamous NSCLC without known actionable genomic alterations. Patients will be randomized 1:1 to receive either ENHERTU plus pembrolizumab or pembrolizumab, platinum-based chemotherapy and pemetrexed

The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review (BICR). The key secondary endpoint is overall survival. Additional secondary endpoints include PFS as assessed by investigator, objective response rate and duration of response as assessed by BICR and investigator and safety.

DESTINY-Lung06 will enroll approximately 686 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer globally and is the leading cause of cancer-related death in both men and women.6 More than 2.48 million lung cancer cases were diagnosed in 2022, with 1.8 million deaths globally.6 NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases. 7 Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 10% will live beyond five years after diagnosis.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumor types.10 HER2 overexpressing NSCLC occurs in up to approximately 20% of patients with NSCLC and is associated with poor treatment response and worse clinical outcomes.11,12,13,14,15 For patients with HER2 overexpressing metastatic non-squamous NSCLC, one of the current recommended first-line treatments is pembrolizumab plus platinum-based chemotherapy and pemetrexed. 1,2,3 Improved outcomes for immunotherapy-based treatments correlate with higher PD-L1 levels, underscoring the need for more targeted treatment options for patients with PD-L1 TPS <50%.4 There currently are no HER2 directed medicines approved in the first-line setting for HER2 overexpressing NSCLC.

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

(Press release, Daiichi Sankyo, OCT 30, 2025, View Source [SID1234657172])

Lantern Pharma to Present AI-Driven Cancer Drug Development & Research Platforms at Inaugural AI for Biology and Medicine Symposium at UNT

On October 30, 2025 Lantern reported it will present two commercially deployed AI research platforms at the inaugural AI for Biology and Medicine (AI4BM) symposium at the University of North Texas. The symposium, hosted by Dr. Serdar Bozdag and the newly established Center for Computational Life Sciences, brings together leading researchers advancing the intersection of artificial intelligence and biomedicine.

The Lantern Pharma team will deliver two presentations demonstrating how machine learning is transforming drug development and precision oncology through specific AI modules that are already delivering value to Lantern’s drug development efforts and other pharmaceutical companies and researchers:

"Machine Learning Ensemble Models for In Silico Screening and Prediction of Blood-Brain Barrier Permeability: A Comprehensive Approach Using Molecular Fingerprints and Descriptors". This presentation will showcase predictBBB.ai, Lantern’s commercially deployed platform that achieves 94.1% accuracy in predicting blood-brain barrier permeability—placing it at the top of the Therapeutic Data Commons leaderboard. The platform predicts BBB permeability in days rather than the months or years required by traditional methods, with the ability to screen 200,000 drug candidates in under a week. The ensemble model has been blindly validated on over 1,300 unseen molecules, demonstrating both accuracy and scalability for pharmaceutical companies developing CNS-targeted therapeutics and is available now as a commercial-ready resource.
"Machine Learning Models for Liquid Biopsy-Based Treatment Response Prediction and Biomarker Discovery in Cancer" Lantern will demonstrate LBx-AI, a production-ready platform that transforms liquid biopsy data into actionable insights with 86% accuracy in predicting treatment response for non-small cell lung cancer patients. Using a novel pathway-level engineering approach, the platform identifies complex biomarkers and pathway analytics that would be missed by traditional single-mutation analysis—with 20 out of 21 significant predictive markers being engineered pathway features. Beyond treatment prediction, LBx-AI can infer solid tumor characteristics from circulating tumor DNA, including accurate prediction of PD-L1 expression levels (0.76 Pearson correlation). Lantern is actively collaborating with world-class research institutions to further validate and improve the models’ performance across a number of tumor types, including GBM, and breast cancer.
Lantern believes that the platforms stand apart through three key differentiators: proven commercial deployment, dramatically compressed drug development timelines, and the generation of novel insights previously inaccessible through conventional methods. While traditional BBB permeability testing and biomarker discovery require months to years of laboratory work, Lantern’s AI models deliver comprehensive insights for drug development, candidate optimization, and target identification within days—maintaining enterprise-level scalability throughout. This transformation from lengthy experimental cycles to rapid computational analysis represents a fundamental shift in how pharmaceutical companies can approach drug discovery and development.

These advanced AI models power Lantern’s comprehensive cancer drug development ecosystem, which was initially developed as RADR. LBx-AI serves as a core component of RADR, Lantern’s AI-driven platform that accelerates precision oncology drug development, while predictBBB.ai operates as a standalone service helping pharmaceutical companies and research teams reduce development costs and improve success rates for CNS-targeted therapeutics.

"Our team is excited to share our efforts and platforms with leading researchers at this inaugural AI symposium," said Panna Sharma, President and CEO at Lantern Pharma. "We’re honored to present alongside distinguished researchers and look forward to engaging with the scientific community. Our vision extends beyond these current capabilities—we’re committed to making these powerful AI tools available as open-access platforms, democratizing advanced computational methods for researchers worldwide."

The symposium will feature keynote speaker Dr. Iman Hajirasouliha, Associate Professor of Systems and Computational Biomedicine at Weill Cornell Medicine, member of the Englander Institute for Precision Medicine and the Meyer Cancer Center, and Co-Director of the Tri-I Computational Biology and Medicine Ph.D. program.

For more information about the AI4BM symposium, visit: View Source

(Press release, Lantern Pharma, OCT 30, 2025, View Source;Research-Platforms-at-Inaugural-AI-for-Biology-and-Medicine-Symposium-at-UNT/default.aspx [SID1234657170])

Sapu Nano to present at the 2025 San Antonio Breast Cancer Symposium (SABCS) Highlighting Sapu003 (Deciparticle™ Everolimus)

On October 30, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, reported that Sapu Nano will be featuring its investigational intravenous Deciparticle everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9-12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Sapu Nano is the developer of DeciparticleTM and is part of Sapu family of companies and a joint venture between Oncotelic (OTCQB:OTLC) and Dragon Oversea.

Sapu003 is a novel Deciparticle formulation of everolimus for intravenous administration, designed to overcome the pharmacologic limitations of oral mTOR inhibitors (Afinitor), including poor bioavailability, dose-limiting toxicity, and restricted tumor penetration. Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor-positive (HR )/HER2 metastatic breast cancer and RCC and NET.

Renal Cell Carcinoma (RCC): FDA approved oral Everolimus for advanced RCC after failure of sunitinib and/or sorafenib. Approval was based on RECORD-1 randomized phase III (everolimus 10 mg PO daily vs placebo + best supportive care) showing a PFS benefit (median 4.9 vs 1.9 mo; HR 0.33).
Pancreatic NET (pNET): FDA approved Everolimus for Pancreatic NET (pNET). Approval was based on RADIANT-3 (everolimus vs placebo in progressive, advanced pNET), which significantly prolonged PFS.
GI and Lung NET (lNET): FDA approved Everolimus for GI & lung NET. Approval was based on RADIANT-4 (non-functional, well-differentiated, nonresectable/metastatic GI or lung NET), showing a PFS benefit.
Patients and Investigators – please contact Ingenu for trial participation.

Australia Headquarters
22/456 St Kilda Rd
Melbourne 3004 VIC
Australia
Phone: 1300 633 226
Email: [email protected]

Presentation Session:
Thursday, December 11, 2025 | 5:00 PM – 6:30 PM CST

Abstract Number Presentation Number Title
1834 PS4-04-04 High RICTOR / Low RPTOR Gene Expression Signature as a Predictive Biomarker for Intravenous Everolimus Nanoparticle (Sapu003): Rationale for the First in Human Trial
1702 PS4-04-21 Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing
1811 PS4-06-05 Sapu003: Everolimus for Injection – Pharmacokinetic Rationale for Phase I Evaluation in HR /HER2 Metastatic Breast Cancer

The studies were conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, and reflect a coordinated clinical-translational effort bridging molecular biomarker discovery, pharmacokinetic modeling, and scalable GMP manufacturing of Deciparticle everolimus.

(Press release, Oncotelic, OCT 30, 2025, View Source [SID1234657169])