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HUTCHMED Completes Patient Enrollment of SANOVO Phase III Trial of ORPATHYS® and TAGRISSO® Combination as a First-Line Therapy for Certain Lung Cancer Patients in China

On August 20, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) as a first-line treatment in certain non-small cell lung cancer ("NSCLC") patients whose tumors harbor epidermal growth factor receptor ("EGFR") mutation and MET overexpression (Press release, Hutchison China MediTech, AUG 20, 2025, https://www.hutch-med.com/sanovo-phiii-enrollment-completion/ [SID1234655371]). The last patient was enrolled on August 18, 2025.

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This Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression. The study will evaluate the efficacy and safety of TAGRISSO in combination with ORPATHYS comparing to TAGRISSO alone, a standard-of-care treatment option for these patients. The primary endpoint of the study is progression free survival ("PFS") as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival (OS), objective response rate ("ORR"), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. Additional details may be found at clinicaltrials.gov, using identifier NCT05009836.

Topline results from the SANOVO study are estimated to be reported in the second half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results would enable a supplementary New Drug Application submission to China’s National Medical Products Administration ("NMPA").

ORPATHYS is an oral, potent and highly selective MET tyrosine kinase inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO is a third-generation, irreversible EGFR TKI.

About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.[1] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[2] The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated ("EGFRm") NSCLC.[3],[4],[5],[6],[7]

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.[8],[9]

About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with ORPATHYS (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS and TAGRISSO Combination Development in EGFR-mutated NSCLC
Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS in combination with TAGRISSO has been studied extensively in these patients in the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results led to the initiation of several Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this advanced setting. Positive data from the SACHI randomized Phase III trial led to the filing of a third NDA in China. Strong data from the SAVANNAH single-arm Phase II study was recently presented at the European Lung Cancer Congress (ELCC) in March 2025 demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The SAFFRON randomized Phase III trial is progressing. Following AstraZeneca’s consultation with the US Food and Drug Administration ("FDA"), we look forward to completing the SAFFRON trial as soon as possible to support potential US and other global registration filings.

SACHI: The SACHI China Phase III study evaluated the combination of ORPATHYS and TAGRISSO for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC after progression on EGFR TKI compared to platinum-based doublet chemotherapy. Results were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025. Based on the data from the SACHI study, the combination of ORPATHYS and TAGRISSO received approval from the China NMPA for the treatment of patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy in June 2025.

SAFFRON: In 2023, ORPATHYS and TAGRISSO received Fast Track Designation from the US FDA in this setting. The global SAFFRON Phase III trial is currently ongoing to assess the ORPATHYS plus TAGRISSO combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.

CorriXR Therapeutics Secures $1M Investment from State of Delaware

On August 19, 2025 CorriXR Therapeutics, Inc., a pioneering oncology-focused biotherapeutics company, reported a significant milestone with a $1M investment from the State of Delaware (Press release, CorriXR Therapeutics, AUG 19, 2025, View Source [SID1234655390]). This funding will be instrumental in advancing CorriXR’s lead program aimed at developing next-generation treatments for solid tumors, with particular focus on head and neck, and lung cancers. This investment not only underscores the potential of CorriXR’s cutting-edge therapies but also highlights Delaware’s commitment to supporting innovative early-stage companies.

"We’re excited to have the State of Delaware participate in our Series A financing round as we advance toward our first-in-human clinical trial," said Eric Kmiec, Ph.D., founder & CEO of CorriXR. "This investment will be critical as we complete preclinical studies, scale-up manufacturing, and prepare our investigational new drug (IND) submission."

The State of Delaware’s investment in CorriXR is the first $1M investment from the Delaware Accelerator & Seed Capital Program (DASCP), one of four programs awarded under the State Small Business Credit Initiative (SSBCI) federal program from the U.S. Treasury Department. The Division of Small Business is administering Delaware’s $60.9 million SSBCI award aimed at providing access to capital for start-up and early-stage businesses.

"Our first $1 million investment is proof that Delaware’s path to becoming the Mid-Atlantic hub for Innovation is well underway," said Delaware Division of Small Business Director CJ Bell. "Supporting companies like CorriXR to scale isn’t just good business – it’s the blueprint for turning that vision into reality."

"This is how Delaware wins the future, with CorriXR demonstrating the power of turning research into real solutions," said Delaware Governor Matt Meyer. "By working closely with experts at the Gene Editing Institute, CorriXR is making promising CRISPR therapies a reality for patients faster than ever. This is exactly why the SSBCI program exists—because supporting innovation today means better treatments, stronger businesses, and a brighter future for Delaware."

Kelonia Therapeutics Doses First Patient in Phase 1 inMMyCAR Study Evaluating in vivo CAR T-Cell Therapy for Relapsed and Refractory Multiple Myeloma

On August 19, 2025 Kelonia Therapeutics, Inc., a biotech company revolutionizing in vivo gene delivery, reported that the first patient has been dosed in the inMMyCAR study, a Phase 1 clinical trial evaluating KLN-1010, a novel in vivo gene therapy that generates anti-BCMA CAR-T cells, in patients with relapsed and refractory multiple myeloma (Press release, Kelonia Therapeutics, AUG 19, 2025, View Source [SID1234655389]).

"KLN-1010 offers hope to multiple myeloma patients who can’t access today’s CAR-T cell therapies," said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. "This first-in-human dosing marks a major milestone toward a future where CAR-T benefits can be delivered without preparative chemotherapy or bespoke manufacturing delays, and at virtually any hospital around the world. Beginning our Phase 1 inMMyCAR study is not only pivotal for patients, but for the entire field. It’s the starting point for transforming CAR-T cell therapies with our in vivo Gene Placement System (iGPS) technology."

Professor Simon Harrison, MBBS, MRCP(UK), FRCPath(UK), FRACP, Ph.D., Director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre, Melbourne, Australia and inMMyCAR Lead Investigator, added, "Multiple myeloma can be a challenging disease to treat as most patients experience relapse after initial treatment, and many become resistant to currently available therapies. In vivo CAR-T cell therapies would be transformative for these patients, providing rapid access to potentially life-saving treatments. We’re at a pivotal moment, in which we’re taking important steps to make such therapies a reality in Australia through highly novel clinical trials, and I’m proud to play a role in ushering in these innovative therapies."

inMMyCAR is a multi-center Phase 1, open-label, dose-escalation clinical trial designed to assess the safety and preliminary efficacy of a single dose of KLN-1010. The first patient was dosed at Royal Prince Alfred Hospital, Sydney, Australia, by inMMyCAR Investigator, Professor Joy Ho, MB.BS. (Hons), D.Phil (Oxon), FRACP, FRCPA, FFSc (RCPA).

"Dosing the first patient in the inMMyCAR Phase 1 study is a tremendous milestone and marks significant advancement towards bringing KLN-1010 to patients who need it most," said Professor Ho. "I and my team are proud to have achieved this proficiently. As an in vivo CAR-T cell therapeutic candidate, KLN-1010 has the potential to deliver the full promise of CAR-T cell therapies without the complex manufacturing requirements, lengthy production timelines and toxic lymphodepleting chemotherapy that ex vivo CAR-T cell therapies require. We believe it has the potential to revolutionize CAR-T therapy in myeloma."

About inMMyCAR

inMMyCAR is a Phase 1, open-label, dose-escalation clinical trial designed to assess the safety, tolerability, pharmacology and preliminary efficacy of a single dose of KLN-1010 in up to 40 patients. The primary endpoints are incidence and severity of treatment-emergent adverse events (TEAEs), including dose limiting toxicities (DLTs), and to establish the recommended Phase 2 dose of KLN-1010. KLN-1010 has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA). This Phase 1 clinical trial marks the first time KLN‑1010 will be evaluated in humans. Additional information and study site information may be found on clinicaltrials.gov (NCT07075185).

About Relapsed and Refractory Multiple Myeloma

Multiple myeloma is a hematologic malignancy characterized by the proliferation of plasma cells in the bone marrow, leading to bone destruction, anemia, renal dysfunction, and immunosuppression. It is driven by complex genetic and epigenetic alterations that promote malignant cell survival and resistance to apoptosis. Relapsed and refractory multiple myeloma is characterized by clonal evolution, drug resistance, and increased disease heterogeneity, heightening the need for accessible, personalized therapeutic strategies.

About KLN-1010

KLN‑1010 is an investigational in vivo gene therapy that generates anti-BCMA CAR-T cells, targeting a protein expressed on the surface of multiple myeloma cells. Unlike traditional CAR‑T treatments, KLN‑1010 is administered to patients via direct transfusion and is designed to generate durable CAR‑T cells inside the body after a single dose, potentially eliminating the need for long wait times to receive treatment. This may overcome several limitations faced by current CAR-T approaches, including limited access to treatment and preconditioning chemotherapy.

Zai Lab Announces China National Medical Products Administration Grants Innovative Medical Device Designation for Tumor Treating Fields for Patients with Pancreatic Cancer

On August 19, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for Tumor Treating Fields (TTFields) for patients with pancreatic cancer based on the positive results from the Phase 3 PANOVA-3 trial (Press release, Zai Laboratory, AUG 19, 2025, View Source [SID1234655388]). The Innovative Medical Device Designation allows Zai Lab to take advantage of an expedited approval procedure for TTFields that offers opportunities for the NMPA to prioritize the allocation of review resources to expedite the regulatory review and approval process.

"We are excited that TTFields has been granted the Innovative Medical Device Designation, a status that offers expedited registration and priority review by the NMPA. This designation also allows us to submit the application in China before approval in the country of origin," said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. We are on track to submit for regulatory approval in China in the second half of 2025 and look forward to collaborating closely with the NMPA throughout the review process."

The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau and Taiwan, collectively).

In August 2019, the NMPA granted Innovative Medical Device Designation for Optune in China for the treatment of newly diagnosed and recurrent glioblastoma (GBM). Zai Lab subsequently submitted the regulatory application in September 2019 and received approval in May 2020. Optune is a registered trademark of Novocure GmbH, and Zai Lab markets Optune under license from Novocure GmbH.

About PANOVA-3

PANOVA-3 is an international prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of TTFields therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

About Pancreatic Cancer in China

Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases and 131,203 cancer deaths in 2022, and it is the sixth leading cause of cancer mortality in China1. Pancreatic cancer has a 5-year survival rate of less than 10%, making it the malignancy with the lowest survival rate in China 2.

The patients with locally advanced, unresectable pancreatic cancer are no longer operable, so chemotherapy with or without radiation is the only treatment option, with a median overall survival only nine to twelve months.

1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590.

2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) is a cancer therapy that uses electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibitors, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effects on cancer cells, visit tumortreatingfields.com.

VantAI and Halda Therapeutics Forge Alliance to Discover Next-Generation RIPTAC Medicines

On August 19, 2025 VantAI, the leader in generative AI for proximity drug discovery, and Halda Therapeutics, the pioneer of RIPTAC (Regulated Induced Proximity Targeting Chimeras) therapeutics, reported a strategic research collaboration worth over $1 billion in total potential value, inclusive of upfront and milestone payments across multiple targets (Press release, Halda Therapeutics, AUG 19, 2025, View Source [SID1234655387]). This landmark alliance combines two category-defining platforms to accelerate the discovery and development of selective proximity-based therapies across cancer and immunology indications. The agreement includes upfront payments, research support, success-based development and commercial milestones, and tiered royalties on net sales, with a path to expand the collaboration over time.

Under the partnership, VantAI will leverage its Neo-1 foundation model and NeoLink high-throughput structural proteomics platform to rapidly identify and validate novel, context-specific target–effector pairs. These pairs—across both oncology and immunology—will feed directly into Halda’s proprietary RIPTAC development pipeline, which harnesses a distinctive "hold-and-kill" mechanism to achieve potent, cell-selective effects in disease-relevant tissues. By pairing Halda’s validated modality with VantAI’s AI-driven rational drug design engine, the partnership is poised to deliver the next generation of selective, proximity-based therapeutics tailored to disease-specific signatures.

"Induced proximity is poised to unlock a new and exciting chapter of medicine, including but also beyond protein degradation," said Zachary Carpenter, Co-Founder and CEO of VantAI. "Halda is leading this next wave, already demonstrating its potential in the clinic. Together, we’re advancing a new generation of RIPTACs—leveraging the unique properties of this modality to address previously inaccessible targets, with the potential to meaningfully impact patients underserved by current treatment options."

"VantAI’s proprietary platform enables the systematic rewiring of protein interactions with precision," said Christian Schade, President and CEO of Halda Therapeutics. "By pairing Halda’s novel RIPTAC modality with VantAI’s AI-driven rational drug design engine, the partnership will complement platform discovery efforts and will help deliver the next generation of selective, proximity-based therapeutics tailored to disease-specific signatures." Halda’s lead candidate, HLD-0915, is currently advancing through Phase 1/2 clinical trials in metastatic castration-resistant prostate cancer (mCRPC).