Phase 2 Trial Shows Promise: Camrelizumab Plus Chemotherapy Effective for Advanced Nasopharyngeal Cancer in Non-Endemic Regions
• A phase 2 trial demonstrates that combining camrelizumab immunotherapy with induction chemotherapy and chemoradiotherapy achieved an 84% 3-year disease-free survival rate in advanced nasopharyngeal cancer patients.
• The treatment regimen showed particularly strong efficacy in patients with high tumor burden (T4 or N3 stage), with 80% of nasopharyngeal lesions and 100% of lymph nodes achieving complete response after treatment.
• The combination therapy demonstrated manageable safety profile, with most adverse events being well-tolerated and no unexpected severe toxicities reported.
Balstilimab Plus Botensilimab Shows Enhanced Response in MSS mCRC Without Liver Metastases
• Preliminary phase 2 data shows balstilimab combined with botensilimab yields a higher objective response rate in MSS mCRC patients without liver metastases.
• The combination of botensilimab 75 mg Q6W plus balstilimab showed a confirmed ORR of 19% and a disease control rate of 55%.
• The median duration of response has not been reached, with 70% of responses ongoing, indicating durable efficacy of the combination therapy.
• A phase 3 trial is planned using botensilimab 75 mg with balstilimab 240 mg, based on the favorable safety and efficacy profile observed.
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.
JMT103 Demonstrates Efficacy in Unresectable Giant Cell Tumor of Bone
• JMT103, a novel therapy, shows promising efficacy in treating unresectable or surgically-challenging giant cell tumor of bone (GCTB).
• The Phase Ib/II study demonstrated a notable objective tumor response rate (OTR) based on histopathological or radiological evaluation.
• Treatment with JMT103 led to clinically meaningful reductions in pain and improvements in daily functioning for GCTB patients.
• The safety profile of JMT103 was manageable, with adverse events consistent with the mechanism of action and manageable with supportive care.
Sacituzumab Govitecan Demonstrates Efficacy in HR+/HER2- Metastatic Breast Cancer
• Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) compared to chemotherapy in patients with HR+/HER2- metastatic breast cancer.
• The phase 3 EVER-132-002 trial included patients who had received two to four prior chemotherapy regimens, showing SG's benefit in heavily pre-treated populations.
• SG demonstrated a manageable safety profile, supporting its potential as a valuable treatment option for this patient population in regions including mainland China, Republic of Korea and Taiwan.
• The study's findings contribute to addressing the unmet need for effective therapies in HR+/HER2- metastatic breast cancer, particularly after multiple lines of treatment.
PD-1 Blockades Show Feasibility and Tolerability in Elderly Patients with Metastatic Esophageal Squamous Cell Carcinoma
• A retrospective study evaluates the effectiveness and safety of PD-1 blockade monotherapy in elderly patients (≥65 years) with metastatic esophageal squamous cell carcinoma (ESCC).
• Results showed a 23.1% objective response rate (ORR) and a 56.4% disease control rate (DCR) with PD-1 blockade, suggesting potential benefits in this population.
• The median overall survival (OS) was 10.9 months, with ECOG performance status and number of metastatic lesions identified as independent prognostic factors.
• While generally tolerable, the study highlights the need for vigilance regarding immune-related adverse events, particularly pneumonitis and liver function abnormalities, in elderly patients.
Ivonescimab Monotherapy Shows Significant PFS Improvement in NSCLC
• Ivonescimab monotherapy reduced the risk of disease progression or death by 49% compared to pembrolizumab in PD-L1 positive advanced NSCLC patients.
• The HARMONi-2 trial demonstrated a median progression-free survival of 11.14 months with ivonescimab versus 5.82 months with pembrolizumab.
• Summit Therapeutics plans to initiate the HARMONi-7 Phase III trial in early 2025, focusing on first-line PD-L1 high advanced NSCLC.
• Phase II data of ivonescimab in perioperative NSCLC showed encouraging major pathological response and pathological complete response rates.
Summit Therapeutics Completes Enrollment in Phase III HARMONi Trial and Receives FDA Fast Track Designation for Ivonescimab
• Summit Therapeutics has completed enrollment in the Phase III HARMONi trial evaluating ivonescimab plus chemotherapy for EGFR-mutated NSCLC after TKI failure.
• The FDA granted Fast Track designation to ivonescimab in combination with platinum-based chemotherapy for EGFR-mutated NSCLC post EGFR-TKI therapy.
• HARMONi is a multi-regional trial conducted in North America, Europe, and China, with topline data expected in mid-2025.
• Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, has shown promise in clinical trials, including HARMONi-2 where it outperformed pembrolizumab.
Pyrotinib Plus Metronomic Vinorelbine Shows Efficacy in HER2+ Advanced Breast Cancer Post-Trastuzumab
• A phase 2 trial in China demonstrated that pyrotinib combined with metronomic vinorelbine is effective in HER2-positive advanced breast cancer patients after trastuzumab failure.
• The combination therapy achieved a median progression-free survival of 13.5 months and an overall response rate of 38.9% in the studied patient population.
• The treatment regimen showed a manageable safety profile, with the most common adverse events being diarrhea, nausea, and vomiting, and no grade 4/5 events reported.
• Researchers suggest this dual-oral regimen is a feasible option where antibody-drug conjugates are not readily accessible, warranting further investigation in larger trials.
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