Fudan University Shanghai Cancer Center
🇨🇳China
China's NMPA Grants Conditional Approval to Tazemetostat for EZH2-Mutant Follicular Lymphoma
• China's National Medical Products Administration (NMPA) has granted conditional approval to tazemetostat (Tazverik) for adult patients with relapsed or refractory EZH2-mutated follicular lymphoma who have received at least two prior systemic therapies.
• Tazemetostat is the first and only EZH2 inhibitor approved in China, representing HUTCHMED's fourth approved product and its first in hematological malignancies, following previous approvals in the US and Japan.
• The approval was supported by a Phase II bridging study in China and international clinical trials, with the ongoing SYMPHONY-1 trial serving as the confirmatory study to validate clinical benefits.
Everest Medicines Initiates First-in-Human Trial of Personalized mRNA Cancer Vaccine EVM16
• Everest Medicines has dosed the first patient with EVM16, its proprietary personalized mRNA cancer vaccine, in a first-in-human trial at Peking University Cancer Hospital in China.
• The trial will evaluate EVM16's safety, immunogenicity, and efficacy both as monotherapy and in combination with PD-1 antibody in patients with advanced or recurrent solid tumors.
• Preclinical studies demonstrated synergistic anti-tumor effects when EVM16 was combined with PD-1 antibodies, suggesting potential clinical benefits for cancer patients with limited treatment options.
Akeso's Gumokimab (IL-17 mAb) Application Accepted for Psoriasis Treatment in China
• Akeso's gumokimab, an IL-17 targeting monoclonal antibody, has its NDA accepted by China's NMPA for treating moderate to severe plaque psoriasis.
• Clinical trials showed gumokimab's rapid efficacy, with PASI 75 response rates approaching 96% at week 12 and sustained improvement over 52 weeks.
• Safety profiles of gumokimab were comparable to placebo, indicating good tolerability, which addresses the need for safer psoriasis treatments.
• Akeso aims to meet diverse patient needs by combining gumokimab with other drugs like ebronucimab, enhancing their autoimmune disease product synergy.
Camrelizumab Plus Chemotherapy Shows Promise in Gastric and GEJ Adenocarcinoma
• The phase 2 FDZL-001 trial investigated camrelizumab plus nab-paclitaxel, oxaliplatin, and fluorouracil (Nab-POF) for gastric/GEJ adenocarcinoma.
• The combination therapy demonstrated a 75% R0 resection rate and an 88.5% overall response rate in treated patients.
• After 3 years, the overall survival rate was 62.8%, and the progression-free survival rate was 56.9%, indicating durable responses.
• The study suggests this regimen offers a new treatment option for initially unresectable, locally advanced, or metastatic gastric/GEJ adenocarcinoma.
Fruquintinib Plus Sintilimab Shows Promise in Advanced Renal Cell Carcinoma
• A Phase Ib/II trial of fruquintinib plus sintilimab demonstrates promising efficacy in both treatment-naive and previously treated advanced clear cell renal cell carcinoma (ccRCC) patients.
• In treatment-naive patients, the combination therapy achieved a confirmed objective response rate (ORR) of 68.2% with an 18-month progression-free survival rate of 59.4%.
• Previously treated patients experienced a 60.0% confirmed ORR and a median progression-free survival of 15.9 months with the fruquintinib and sintilimab regimen.
• The combination was generally well-tolerated, with manageable adverse events, supporting further investigation in the ongoing Phase III FRUSICA-02 study.
Phase 2b Trial of Glecirasib in KRAS G12C-Mutated Non-Small-Cell Lung Cancer
A phase 2b trial investigates the efficacy of Glecirasib in treating KRAS G12C-mutated non-small-cell lung cancer, involving multiple institutions across China and the USA.
Tislelizumab Triplet Demonstrates Promising Results in Metastatic TNBC
• A phase 2 trial reveals that tislelizumab combined with sitravatinib and nab-paclitaxel shows meaningful responses in patients with untreated locally advanced or recurrent triple-negative breast cancer (TNBC).
• The triplet therapy achieved an objective response rate (ORR) of 75.7% and a disease control rate (DCR) of 97.3% in evaluable patients, indicating strong anti-tumor activity.
• Median progression-free survival (PFS) was 10.6 months across all patients, with CD8-positive patients showing a longer PFS of 15.8 months, suggesting CD8 status as a potential predictive biomarker.
• The combination therapy presented an acceptable safety profile, though most patients experienced treatment-related adverse events (TRAEs), with grade 3 or higher events occurring in 43.2% of patients.
Camrelizumab and Apatinib Show Promise in Neoadjuvant Treatment of TNBC
• Camrelizumab plus chemotherapy significantly improved pathologic complete response (pCR) rates in early or locally advanced triple-negative breast cancer (TNBC).
• Apatinib combined with sintilimab and chemotherapy demonstrated a high pCR rate of 70.6% in early TNBC, suggesting synergistic effects.
• Both camrelizumab and apatinib regimens exhibited manageable safety profiles, supporting their potential as new neoadjuvant therapeutic options.
• Biomarker analysis in the apatinib study identified correlations between immune response and pCR, offering insights for predicting treatment efficacy.
SHR-A1811 Demonstrates Promising Activity in HER2-Expressing Breast Cancer Subtypes
• SHR-A1811, a novel anti-HER2 ADC, shows promising anti-tumor activity and acceptable safety in HR-positive/HER2-low breast cancer in a phase 2 trial.
• In HR-positive/HER2-low breast cancer, SHR-A1811 achieved an objective response rate of 74.3% in the first stage of a phase 2 trial.
• The FASCINATE-N trial showed SHR-A1811 monotherapy had similar pathological complete response rates compared to standard chemotherapy in HER2-positive breast cancer.
• Common treatment-related adverse events with SHR-A1811 include neutropenia, leukopenia, anemia, nausea, asthenia, and vomiting, with manageable safety profiles.
Disitamab Vedotin Plus Toripalimab Shows Promise in Muscle-Invasive Bladder Cancer
• Phase 2 trial RC48-C017 shows promising efficacy and acceptable safety of neoadjuvant disitamab vedotin plus perioperative toripalimab in HER2-expressing muscle-invasive bladder cancer (MIBC).
• Pathological complete response (pCR) was observed in 63.6% of patients who underwent radical cystectomy, with a pathological response rate of 75.8%.
• The 12-month event-free survival (EFS) rate was 90.5%, and the 12-month overall survival (OS) rate was 95.5% in the intent-to-treat (ITT) population.
• Treatment-related adverse events were manageable, with no new safety signals identified, supporting the potential of this combination as a neoadjuvant treatment option.
Cadonilimab Plus Chemotherapy Improves Survival in Advanced Cervical Cancer
• The addition of cadonilimab to platinum-based chemotherapy, with or without bevacizumab, significantly improved progression-free survival (PFS) in patients with advanced cervical cancer.
• Overall survival (OS) was also significantly enhanced with the cadonilimab combination, showing a clinically meaningful benefit in the first-line treatment setting.
• The COMPASSION-16 trial demonstrated a manageable safety profile for the cadonilimab combination, supporting its potential as a new treatment option.
• Cadonilimab may offer a suitable treatment option for individuals who are not eligible for bevacizumab therapy.
Alphamab Oncology's JSKN033 Receives Priority Review for Advanced Malignant Tumors
• Alphamab Oncology's JSKN033, a subcutaneous co-formulation of anti-HER2 bispecific ADC and PD-L1 inhibitor, has been included in Shanghai's pilot program for innovative drug clinical trials.
• The Phase I/II trial (JSKN033-102) will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of JSKN033 in advanced metastatic malignant tumors.
• JSKN033 combines immunotherapy (KN035) and ADC (JSKN003), offering improved safety and convenience through subcutaneous administration, with promising early clinical data.
• The accelerated review aims to expedite the clinical development of JSKN033 in China, potentially providing a more compliant treatment option for cancer patients.
Alphamab Oncology Retracts Announcement on JSKN033 Clinical Trial Inclusion
• Alphamab Oncology has retracted its press release regarding the inclusion of JSKN033, an anti-HER2 bispecific antibody-drug conjugate (ADC), in a pilot program.
• The initial announcement concerned a Phase I/II clinical study evaluating a subcutaneous co-formulation of JSKN033 for HER2-positive cancers.
• The retraction was issued via Cision and advises journalists and readers to disregard the previous news release dated November 13, 2024.
Alphamab Oncology's Anti-HER2 Bispecific ADC Subcutaneous Co-formulation Receives Priority Review in China
• Alphamab Oncology's JSKN033, a subcutaneous co-formulation of anti-HER2 bispecific ADC and PD-L1 inhibitor, has been included in Shanghai's pilot program for accelerated clinical trial review.
• The Phase I/II trial (JSKN033-102) will assess the safety, pharmacokinetics, and anti-tumor activity of JSKN033 in patients with advanced metastatic malignant tumors.
• JSKN033 combines immunotherapy (KN035) and ADC (JSKN003), offering improved safety and convenience through subcutaneous administration, with promising early clinical data.
• The accelerated review is expected to expedite the clinical development of JSKN033 in China, potentially providing a more compliant treatment option for cancer patients.
Innovative Therapies for HIV, Infertility, and Cancer Highlighted at CIIE
• Gilead Sciences has submitted a market application in China for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, following positive Phase 3 trial results.
• Organon unveiled SJ02, a long-acting recombinant human follicle-stimulating hormone, potentially China's first, to expand fertility treatment options.
• Pfizer announced China's approval of Talazoparib for prostate cancer, targeting a genetic mutation found in 25% of patients for individualized treatment.
• Johnson & Johnson's Teclistamab Injection, the first bispecific antibody, has been approved in China for relapsed or refractory multiple myeloma.
Antengene to Present Selinexor Data from Late-Stage Trials at ASH 2024
• Antengene will present Phase III results of weekly selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in Chinese patients with relapsed/refractory multiple myeloma.
• Preliminary results from a Phase I/II study of selinexor combined with tislelizumab in relapsed/refractory extranodal NK/T-cell lymphoma will also be presented.
• The presentations highlight selinexor's potential in treating hematologic malignancies through its novel mechanism of action targeting the nuclear export protein XPO1.
Antengene's Selinexor Shows Promise in Multiple Myeloma and Lymphoma Studies
• Antengene will present Phase III trial results of weekly selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM).
• Preliminary results from a Phase I/II study of selinexor combined with tislelizumab in relapsed/refractory extranodal NK/T-cell lymphoma (R/R ENKTL) will also be presented.
• Selinexor, an oral selective inhibitor of nuclear export (SINE) compound, aims to restore tumor suppressor protein activity and reduce oncogenic protein levels.
Antengene to Present Selinexor Data from Two Late-Stage Studies at ASH 2024
• Antengene will present data from a Phase III study of weekly selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM).
• Preliminary results from a Phase I/II study (TOUCH) of selinexor combined with tislelizumab in patients with relapsed/refractory extranodal NK/T-cell lymphoma (R/R ENKTL) will be presented.
• Selinexor, an oral selective inhibitor of nuclear export (SINE) compound, has a novel mechanism of action that promotes tumor suppressor protein activity and reduces oncogenic protein levels.
Antengene to Present Selinexor Data from Phase III Multiple Myeloma and Phase I/II Lymphoma Studies at ASH 2024
• Antengene will present Phase III results of weekly selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in Chinese patients with relapsed/refractory multiple myeloma.
• Preliminary results from a Phase I/II study of selinexor combined with tislelizumab in relapsed/refractory extranodal NK/T-cell lymphoma will also be presented.
• The presentations will occur at the American Society of Hematology (ASH) Annual Meeting on December 9, 2024, in San Diego, CA.
Antengene to Present Selinexor Data in Relapsed/Refractory Multiple Myeloma and Extranodal NK/T-Cell Lymphoma at ASH 2024
• Antengene will present Phase III Bench study results of weekly selinexor, bortezomib, and dexamethasone (SVd) versus twice-weekly bortezomib and dexamethasone (Vd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM).
• Preliminary results from a Phase I/II study (TOUCH) evaluating selinexor combined with tislelizumab in relapsed/refractory extranodal NK/T-cell lymphoma (R/R ENKTL) will be presented.
• Selinexor, an oral selective inhibitor of nuclear export (XPO1), offers a novel mechanism of action with synergistic effects and rapid onset, potentially improving outcomes in hematologic malignancies.
© Copyright 2025. All Rights Reserved by MedPath