Recent Approvals and Clinical Advances in Oncology Targeted Therapies (Part XV) | Key Highlights (96)

Introduction | INTRODUCTION

EGFR/KRAS

In November, Alpha Biopharma/AstraZeneca's Class 1 new drugZolitinib Hydrochloride Tablets(Zorifertinib, Zereni)^®) has been approved for marketing in China, indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletion (19Del) or exon 21 (L858R) substitution mutations and are accompanied by central nervous system (CNS) metastases. The drug is an orally administered, reversibleEGFR Activating mutations (L858R and 19Del) tyrosine kinase activity inhibitors, specifically designed for the treatment of advanced NSCLC patients with central nervous system metastases.

In November, Beirunda Pharmaceutical's EGFR inhibitorRezivertinib Mesylate Capsules(Rui Bi Da^®) approved for new indications, first-line treatment withEGFRPatients with locally advanced or recurrent metastatic NSCLC with sensitizing mutations. In May, the drug was approved in China for the first time, indicated for patients who experienced disease progression during or after prior EGFR-TKI treatment and were confirmed by testing to have...EGFRAdult patients with locally advanced or metastatic NSCLC who are T790M mutation-positive.

In November, CHIATAI TIANQING filed a KRAS G12C inhibitorGesorese(Garsorasib, D-1553, Anfangning)^®) has been approved for marketing in China, intended for the treatment of adult patients with advanced NSCLC harboring the mouse sarcoma virus oncogene (KRAS) G12C mutation who have received at least one systemic therapy. Currently, there are four approved treatments globally.KRASG12C inhibitor. In China, Innovent Biologics'FuzelrezApproved for marketing in August.

In November, Hansoh Pharma's third-generation EGFR-TKIAlmonertinib Mesylate Tablets(Ameile^®) New Indication Marketing Application Accepted, Combined with Chemotherapy for TreatmentEGFRAdvanced Lung Cancer with Mutations. Almonertinib has previously been approved in China for two indications: second-line treatment of patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI treatment and are positive for the T790M mutation; first-line treatment for patients with...EGFRAdult patients with locally advanced or metastatic NSCLC who are positive for the 19del or L858R mutation.

In October, CHIATAI TIANQING's Category 1 new drugTQB3002Approved for clinical use, intended for advanced malignant tumors. Research shows that targetingEGFRIn pathway-acquired resistance, the C797S mutation is the primary mechanism of osimertinib-acquired resistance, and currently, a large number of fourth-generation EGFR-TKIs are under research.

In November, Jiyu Pharmaceutical developedKRASG12C InhibitorJMKX001899Initiate Phase III Clinical Trial, Comparing Docetaxel for Previously Treated PatientsKRASPatients with G12C mutation-positive advanced or metastatic NSCLC. Currently, in ChinaKRASSix G12C inhibitors are in Phase III clinical trials.

In November, AstraZeneca's Class 1 new drug AZD0022 Clinical Trial Application Accepted, Aiming to Develop Treatment for Solid Tumors. This product is currently in Phase 1 clinical trials internationally. Globally, there are already dozens of targetedKRASNew drugs for G12D have entered the clinical research stage, with the fastest-progressing products already in Phase 2 clinical trials.

HER2/TROP2

In November, Kelun-Biotech announcedLukang Satuzumab(sac-TMT, Alpha Biopharma^®) has been approved for marketing, indicated for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received at least two systemic treatments (at least one of which targets the advanced or metastatic stage). This drug is the first TROP2 ADC drug produced in China and the second globally to be approved for marketing. The indications applied for this drug also include the treatment of locally advanced or metastatic disease that has failed EGFR-TKI (and platinum-based chemotherapy). EGFRMutation NSCLC.

In November, Innovent IBI354A clinical application for breakthrough therapy designation has been proposed, with the indication being platinum-resistant ovarian cancer. Currently, there is no HER2 ADC approved globally for the treatment of ovarian cancer. The drug is undergoing clinical research in China, the United States, and Australia, targeting various advanced malignant tumors, including breast cancer, ovarian cancer, colorectal cancer, and others.

In November, AstraZeneca registered aTrastuzumab DeruxtecanA Phase III Study of First-Line Treatment with DS8201a (Enhertu) for HER2-Expressing, Mismatch Repair Proficient (pMMR) Primary Advanced or Recurrent Endometrial Cancer. Since its initial approval in 2019, the drug has been approved for marketing in multiple countries and regions, including the United States, Japan, the European Union, and China, covering indications such as HER2-positive breast cancer, HER2-low breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC, and HER2-positive solid tumors.

In November, the product co-developed by Daiichi Sankyo and AstraZeneca Datopotamab deruxtecan(Dato-DXd) has launched three Phase III clinical trials in the field of advanced non-squamous NSCLC, aiming to explore Dato-DXd in combination with third-generation EGFR-TKI.Osimertiniband PD-1/TIGIT bispecific antibodyRilvegostomigThe effect of combination therapy, to understand the potential of Dato-DXd in different treatment lines and in treating different types of lung cancer patients. In addition, a new marketing application for this drug has been submitted in the United States for the treatment of locally advanced or metastaticEGFRMutated NSCLC adult patients.

In November, Jazz Pharmaceuticals announced that the U.S. FDA had granted accelerated approval to its HER2-targeted bispecific antibody developed in collaboration with Zymeworks.Zenidatamab(Zanidatamab, Ziihera) has been approved for marketing in China to treat patients with previously treated, unresectable, locally advanced or metastatic HER2-positive biliary tract cancer. Currently, the drug's marketing application in China has been accepted and included in the priority review process.

Immune Therapy Targets

In November, CHIATAI TIANQING'sBeimusuab(Andewei^®) approved for new indications in China, in combination withAnlotinib Hydrochloride CapsulesFor the treatment of recurrent or metastatic endometrial cancer that is not highly microsatellite unstable (non-MSI-H) or not deficient in DNA mismatch repair (non-dMMR), and has failed or cannot tolerate previous first- and second-line chemotherapy regimens. The drug was previously approved for use in combination with anlotinib, carboplatin, and etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC).

In November, Bristol-Myers Squibb'sNivolumab(Nivolumab, Opdivo)^®) has been approved for a new indication, in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. This therapy is the first immunotherapy approved in China for the first-line treatment of advanced urothelial carcinoma, and O drug has also become the only PD-1 inhibitor currently indicated for both early adjuvant treatment and advanced first-line treatment of urothelial carcinoma.

In November, CHIATAI TIANQING submittedPenpulimabAndAnlotinibNew Indication Application for Combination Therapy Accepted for First-Line Treatment of Advanced Hepatocellular Carcinoma. Previously, both drugs were approved in China for multiple tumor indications. The latest clinical data show that compared to sorafenib, the combination of anlotinib and penpulimab significantly reduces the risk of disease progression or death by 47% and extends progression-free survival by 6.9 months vs. 2.8 months.

In November, Bristol-Myers Squibb Company filed nivolumab/relatlimabFixed-dose combination injection receives a new clinical trial implied permission, intended for use in recurrent or metastatic non-squamous NSCLC with tumor cell PD-L1 expression levels of 1%-49%. This is a LAG-3 targeted therapy combined with a fixed-dose PD-1 inhibitor regimen, which has previously been approved by the U.S. FDA for the treatment of melanoma.

Other Targets

In November, Huadong Medicine reportedSomiromab Injection(Mirvetuximab Soravtansine-gynx, Elahere^®) has been approved for marketing to treat adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy. This drug is the world's first approved FRα ADC, and multiple domestically developed FRα-targeted ADCs in China have entered the clinical stage.

In November, Pfizer filedTalazoparib Tosylate Capsules(talazoparib, Talzenna)^®) has been approved for marketing, to be used in combination with enzalutamide for the treatment of metastatic castration-resistant prostate cancer. This drug is the first PARP inhibitor approved for use in combination with the existing standard treatment (enzalutamide) for adult patients with homologous recombination repair (HRR) mutated mCRPC.

In November, Merck filedBezutifan(Belzutifan, Veliric)^®) has been approved in China for VHL (von Hippel-Lindau) disease-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, or pancreatic neuroendocrine tumors (pNET). Belzutifan was approved by the FDA in 2021, becoming the world's first and currently the only approved HIF-2α (oral hypoxia-inducible factor 2α) inhibitor.

In November, Ying Shi Bio's Category 1 New Drug IN10018The tablet is proposed to be included in the breakthrough therapy category, with the indication being combination therapy.GesolreseFirst-line TreatmentKRASG12C mutation-positive locally advanced or metastatic NSCLC. Public information shows that IN10018 is a FAK inhibitor under research by InventisBio, and Glesorase is a KRASG12C Selective Inhibitor Recently Approved.