Camrelizumab

HAIC with FOLFOX Plus Camrelizumab and Sorafenib Shows Limited Efficacy in Advanced HCC

13 days ago

• A phase II trial investigating hepatic artery infusion of FOLFOX chemotherapy plus camrelizumab combined with sorafenib in BCLC stage C hepatocellular carcinoma failed to meet its primary endpoint, showing a modest 44% objective response rate. • The treatment demonstrated a manageable safety profile with grade ≥3 treatment-related adverse events in 76% of patients, primarily including decreased lymphocyte count (52%) and elevated liver enzymes (44%). • In contrast, a separate trial combining HAIC with camrelizumab and apatinib as conversion therapy for unresectable HCC showed promising results with a 73.7% conversion rate and 47.4% R0 resection rate.

Neoadjuvant Immunochemotherapy Shows Promising Results in Locally Advanced Oral Squamous Cell Carcinoma

24 days ago

• Neoadjuvant immunochemotherapy with camrelizumab plus nab-paclitaxel and cisplatin demonstrated a favorable pathological response in patients with locally advanced oral squamous cell carcinoma, achieving a 69% major pathological response rate and 41.4% pathological complete response rate. • The treatment regimen showed a manageable safety profile with only 6.5% of patients experiencing grade 3-4 treatment-related adverse events, and no delays in surgery occurred due to treatment-related toxicity. • Single-cell analysis revealed that CD4+CXCL13+ T follicular helper cells may serve as a potential predictive biomarker for treatment response, with higher baseline levels correlating with better pathological outcomes.

Innovative Trial Designs Emerge After Immunotherapy Setbacks in Head and Neck Cancer

2 months ago

• Recent phase 3 trials KEYNOTE-412 and JAVELIN Head and Neck 100 failed to show survival benefits when adding immunotherapy to chemoradiotherapy in locally advanced head and neck cancer, prompting researchers to investigate alternative treatment sequences. • Emerging data from phase 2 trials suggests that sequential rather than concurrent immunotherapy administration may be more effective, with neoadjuvant pembrolizumab showing promising pathological response rates and improved disease-free survival. • The phase 3 KEYNOTE-689 trial recently demonstrated statistically significant improvement in event-free survival with perioperative pembrolizumab, potentially establishing a new standard of care for resectable locally advanced head and neck squamous cell carcinoma.

FDA Issues Second Rejection for Rivoceranib/Camrelizumab Combination in Unresectable Liver Cancer

2 months ago

• The FDA has issued a second Complete Response Letter (CRL) for the rivoceranib/camrelizumab combination therapy for unresectable hepatocellular carcinoma, with no specific reasons disclosed for the rejection. • The combination showed significant clinical benefits in the phase 3 CARES-310 trial, including improved overall survival of 23.8 months versus 15.2 months with sorafenib, and higher response rates (26.8% vs 5.9%). • Despite promising efficacy data, manufacturing concerns have plagued the application process, with the initial CRL in May 2024 citing deficiencies related to camrelizumab's manufacturing site inspection.

HLB Group to Resubmit Riboceranib for FDA Approval Following Second Rejection

2 months ago

• HLB Group announced plans to resubmit its targeted anticancer drug riboceranib for FDA approval by May after receiving a second rejection due to manufacturing issues with partner Hangseo Pharmaceutical. • Chairman Jin Yang-gon expressed confidence in a potential FDA decision as early as July, while also revealing plans to pursue European Medicines Agency (EMA) approval in parallel. • HLB Group shares, which initially plummeted following the FDA rejection, rebounded significantly with HLB stock rising 11.40% as investors responded to the company's commitment to pursue approval.

Zimberelimab Plus Lenvatinib Shows Promise in Advanced Cervical Cancer After ICI Failure

2 months ago

• Phase 2 trial results demonstrate that zimberelimab combined with lenvatinib achieved a 33.3% objective response rate in patients with advanced cervical cancer who progressed after prior immune checkpoint inhibitor therapy. • The combination therapy demonstrated remarkable disease control, with 96.7% of patients experiencing stable disease or better, and a median progression-free survival of 7.1 months. • Treatment was well-tolerated with mostly mild to moderate adverse effects, with only 10% of patients experiencing grade 3/4 treatment-related adverse events.

Robust Pipeline of 220+ Drugs Advancing for Gastric Cancer Treatment, Led by Major Pharmaceutical Companies

3 months ago

• DelveInsight's comprehensive analysis reveals over 200 companies actively developing 220+ pipeline therapies for gastric cancer treatment, indicating significant industry investment in addressing this disease. • Key players including BeiGene, Bristol-Myers Squibb, and AstraZeneca are advancing promising candidates like tislelizumab, relatlimab-nivolumab combination, and trastuzumab deruxtecan through clinical trials. • Multiple therapeutic approaches are being explored, from monoclonal antibodies to small molecules, with several drugs in late-stage development including Catumaxomab in Phase III and Tivumecirnon in Phase II trials.

Phase 2 Trial Shows Promise: Camrelizumab Plus Chemotherapy Effective for Advanced Nasopharyngeal Cancer in Non-Endemic Regions

3 months ago

• 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.

ESMO Endorses HLB's CAM-RIVO for First-Line Liver Cancer Treatment Ahead of FDA Decision

3 months ago

• HLB's combination therapy CAM-RIVO has been added to ESMO guidelines as a first-line treatment for hepatocellular carcinoma, receiving a "very strong" clinical evidence rating. • The drug combination demonstrates unprecedented efficacy with a median overall survival of 23.8 months, marking the longest survival data recorded for liver cancer therapy. • The ESMO endorsement comes at a crucial time, with an FDA decision expected by March 20, following the drug's previous approval in China.

Camrelizumab Plus Chemotherapy Shows Promise in Cervical Cancer Treatment with 100% Disease Control Rate

3 months ago

• A new study demonstrates that combining camrelizumab with chemotherapy achieved a 100% disease control rate in cervical cancer patients, compared to 94.87% with chemotherapy alone. • The combination therapy significantly reduced tumor volume and malignancy markers, with an objective response rate of 77.55% and manageable adverse effects. • Patients with stage IIA2 cervical cancer showed particularly notable improvements in tumor volume reduction when treated with the combination therapy.

FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumor Treatment, Showing 40% Response Rate

3 months ago

• The FDA has granted approval to vimseltinib (DCC-3014) for treating symptomatic tenosynovial giant cell tumor (TGCT), based on positive Phase 3 MOTION trial results. • The pivotal MOTION study demonstrated a significant 40% objective response rate for vimseltinib compared to 0% for placebo, with notable improvements in patient mobility and pain. • The twice-weekly oral medication showed a manageable safety profile, with mostly grade 1-2 adverse events, providing a new therapeutic option for TGCT patients.

Novel Bispecific Antibody KN046 Plus Lenvatinib Shows Promise in Advanced Liver Cancer Treatment

3 months ago

• A phase II trial combining KN046, a bispecific antibody targeting PD-L1/CTLA-4, with lenvatinib achieved a 45.5% objective response rate in advanced hepatocellular carcinoma patients. • The treatment demonstrated encouraging efficacy with median progression-free survival of 11.0 months and manageable safety profile, though 47.3% of patients experienced grade ≥3 treatment-related adverse events. • Analysis revealed that circulating tumor DNA status early in treatment may serve as a potential biomarker for predicting treatment response and survival outcomes.

Akeso's Gumokimab (IL-17 mAb) Application Accepted for Psoriasis Treatment in China

4 months ago

• 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

4 months ago

• 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.

Gastrointestinal Cancer Symposium 2025: Key Advances in Treatment Strategies

4 months ago

• Nivolumab plus ipilimumab demonstrates superior progression-free survival compared to nivolumab alone in MSI-H/dMMR metastatic colorectal cancer. • Encorafenib combined with cetuximab and chemotherapy shows significant improvement in overall response rate for BRAF V600E-mutated metastatic colorectal cancer. • TACE plus camrelizumab and rivoceranib extends progression-free survival in patients with unresectable hepatocellular carcinoma, offering a manageable safety profile.

TACE Plus Camrelizumab and Rivoceranib Improves PFS in Unresectable HCC

4 months ago

• The CARES-005 study demonstrated that adding camrelizumab and rivoceranib to TACE significantly prolonged progression-free survival (PFS) in patients with unresectable hepatocellular carcinoma (HCC). • Median PFS was 10.8 months with TACE plus camrelizumab and rivoceranib, compared to 3.2 months with TACE alone (HR 0.34, P<0.0001) at a median follow-up of 13.6 months. • Objective response and disease control rates were also higher in the TACE-CR group, indicating enhanced antitumor efficacy with the combination therapy. • The safety profile of the combination was manageable, with adverse events consistent with those known for TACE, camrelizumab, and rivoceranib.

Radiomics in Rectal Cancer: A Powerful Tool for Diagnosis, Treatment Response Evaluation, and Prognosis Prediction

4 months ago

• Radiomics, an advanced computational approach that extracts quantitative features from medical images, is revolutionizing rectal cancer management by providing more accurate tumor staging and treatment response prediction than conventional imaging methods. • Recent studies demonstrate radiomics' effectiveness in predicting lymph node metastasis, distant metastasis, and pathological complete response to neoadjuvant therapy, with multimodal approaches combining CT, MRI, and ultrasound showing the highest predictive accuracy. • The integration of radiomics with deep learning algorithms and molecular markers represents the future direction of research, potentially enabling more personalized treatment strategies and improved patient outcomes in rectal cancer care.

Anlotinib Maintenance Therapy Shows Promise in Extensive-Stage Small Cell Lung Cancer

4 months ago

• A retrospective study indicates that anlotinib maintenance therapy, particularly when combined with immunotherapy, significantly improves progression-free survival (PFS) and overall survival (OS) in ES-SCLC patients. • The median PFS was 7.2 months for all patients, and the median OS reached 17.6 months, highlighting the potential of anlotinib in prolonging survival in this aggressive cancer. • Combining anlotinib with immunotherapy resulted in a median PFS of 8.2 months and a median OS of 20.1 months, demonstrating a statistically significant improvement compared to anlotinib with chemotherapy. • The study confirms that anlotinib-related adverse events are manageable, with no unexpected toxicities or treatment-related deaths, supporting its safety profile in ES-SCLC maintenance therapy.

Lenvatinib Shows Promise as Second-Line Treatment for Advanced Liver Cancer After Immunotherapy

5 months ago

A phase 2 study reveals that lenvatinib (Lenvima) demonstrates efficacy as a second-line treatment for advanced hepatocellular carcinoma patients who progressed after atezolizumab-bevacizumab therapy. The trial met its primary endpoint with a median progression-free survival of 5.4 months and showed a disease control rate of 84%, establishing lenvatinib as a potential standard treatment option in this setting.

Keytruda Approved in China for Early-Stage NSCLC Treatment

5 months ago

• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy. • The approval is based on the KEYNOTE-671 trial, demonstrating a significant improvement in overall survival and event-free survival. • This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease. • The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.

Drug Development Updates