Sintilimab

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

25 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.

Innovent Biologics to Present Breakthrough Clinical Data for IBI363 PD-1/IL-2 Bispecific Antibody at ASCO 2025

a month ago

• Innovent Biologics will showcase seven oral presentations at ASCO 2025, featuring breakthrough clinical data for its novel PD-1/IL-2α-bias bispecific antibody IBI363 in melanoma, colorectal cancer, and non-small cell lung cancer. • IBI343, Innovent's anti-CLDN18.2 antibody-drug conjugate, secured an oral presentation slot for its Phase 1b data in pancreatic cancer, demonstrating promising potential in this difficult-to-treat malignancy. • The company's robust pipeline of bispecific antibodies and ADCs highlights Innovent's growing position as a leader in the "IO+ADC" space, with multiple candidates advancing toward pivotal-stage development.

Fruquintinib-Sintilimab Combination Meets Primary Endpoint in Phase II/III RCC Trial

2 months ago

• The FRUSICA-2 Phase II/III study evaluating fruquintinib plus sintilimab as second-line treatment for advanced renal cell carcinoma has met its primary endpoint of progression-free survival. • The combination therapy demonstrated improvements in secondary endpoints including objective response rate and duration of response, offering new hope for patients who have progressed on previous therapies. • HUTCHMED and Innovent Biologics plan to submit detailed findings to regulatory authorities and progress toward NDA filings in the coming months.

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.

HUTCHMED Completes Enrollment for Phase II Registration Trial of Fanregratinib in FGFR2-Fusion Cholangiocarcinoma

3 months ago

• HUTCHMED has completed enrollment of 87 patients in a Phase II registration trial evaluating fanregratinib for intrahepatic cholangiocarcinoma patients with FGFR2 fusion/rearrangement. • The single-arm, multi-center study will assess efficacy and safety metrics including objective response rate as the primary endpoint, with topline results expected by late 2025. • The trial targets a significant unmet need, as FGFR2 fusion occurs in 10-15% of IHCC patients, with China seeing over 60,000 new IHCC cases in 2015 and incidence rising 9.2% annually.

OH2 Oncolytic Virus Plus HX008 Shows Promise in Advanced Sarcoma Treatment

3 months ago

• Phase 1/2 trial demonstrates OH2 oncolytic virus combined with HX008 PD-1 inhibitor achieves 16.7% overall response rate in advanced sarcoma patients, with two complete responses observed. • The combination therapy showed favorable safety profile with no serious treatment-related adverse effects, while extending median overall survival to 18.04 months compared to 4.50 months with OH2 monotherapy. • Particularly encouraging responses were seen in angiosarcoma and fibrosarcoma patients, suggesting potential for the combination therapy in neoadjuvant settings for specific sarcoma subtypes.

Anti-PD1 Precision Therapy Shows Promise in Unresectable Stage III NSCLC Trial

3 months ago

• A phase II umbrella trial demonstrated that anti-PD1 based precision induction therapy achieved a 61.7% major pathological response rate in patients with unresectable stage III non-small cell lung cancer. • The PD-L1-positive population receiving chemo-free treatment showed a 55.6% major pathological response rate with lower toxicity, while chemoimmunotherapy achieved a 63.2% response rate in PD-L1 negative/low patients. • Researchers identified BST1 as a novel biomarker that correlates with improved immunotherapy response and immune cell infiltration, potentially enabling more precise patient stratification for treatment.

FDA Tightens Requirements for China-Developed Drugs, Mandates Multi-Regional Trials

3 months ago

• The FDA has rejected multiple China-developed drugs, including Hutchmed's surufatinib and Eli Lilly's sintilimab, citing concerns over single-country clinical trial data. • At least 25 oncology drug applications from China face increased scrutiny, with the FDA emphasizing the need for multi-regional trials to ensure data generalizability across diverse populations. • The regulatory shift impacts China's growing biopharma sector, which has attracted significant Western partnerships, including Merck's recent $1.4 billion deal with Sichuan Kelun Pharmaceutical.

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.

Balstilimab Plus Botensilimab Shows Enhanced Response in MSS mCRC Without Liver Metastases

4 months ago

• 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.

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.

Innovent's IBI343 Receives Breakthrough Therapy Designation in China for Advanced Pancreatic Cancer

4 months ago

• Innovent's IBI343, an anti-CLDN18.2 ADC, has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for advanced pancreatic cancer. • The designation is based on Phase 1 data showing favorable safety and promising antitumor activity in patients who progressed after prior treatment. • In the Phase 1 trial, IBI343 demonstrated a 23.3% overall objective response rate and a median progression-free survival of 5.3 months. • Innovent plans to initiate pivotal trials to confirm IBI343's efficacy and explore its potential in combination therapies for various solid tumors.

Fruquintinib Plus Sintilimab Shows Promise in Advanced Renal Cell Carcinoma

4 months ago

• 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.

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.

Combination Therapies Show Promise in Treating MSS Metastatic Colorectal Cancer

5 months ago

• Combination therapies are being explored to improve immunotherapy efficacy in pMMR/MSS metastatic colorectal cancer (mCRC) patients, who do not typically respond well to single-agent immune checkpoint inhibitors. • Multi-target tyrosine kinase inhibitors combined with ICIs have shown some success in converting 'cold tumors' to 'hot tumors,' enhancing immune response, but results vary across studies. • Dual ICI regimens and combinations with chemotherapy or radiotherapy are under investigation to overcome resistance and improve outcomes in MSS mCRC, with encouraging results in some trials. • Emerging biomarkers like TMB and POLE/POLD1 mutations may help identify MSS mCRC patients who are more likely to benefit from immunotherapy, guiding personalized treatment strategies.

Innovent's Taletrectinib (DOVBLERON®) Receives Expanded Approval in China for ROS1-Positive NSCLC

5 months ago

• China's NMPA has approved Innovent's taletrectinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). • The approval was based on positive outcomes from the Phase II TRUST-I trial, which showed high and durable overall responses. • In TKI-naïve patients, taletrectinib achieved a confirmed objective response rate of 91% and intracranial cORR of 88%. • Taletrectinib is now approved for both first-line and previously treated ROS1-positive NSCLC patients in China.

Camrelizumab and Apatinib Show Promise in Neoadjuvant Treatment of TNBC

5 months ago

• 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.

Fruquintinib Plus Sintilimab Conditionally Approved in China for Advanced pMMR Endometrial Cancer

6 months ago

• The NMPA has granted conditional approval to fruquintinib plus sintilimab for advanced pMMR endometrial cancer after systemic therapy failure. • The approval was based on the FRUSICA-1 phase 2 trial, which showed an objective response rate of 35.6% with the combination therapy. • The median progression-free survival was 9.5 months, and the median overall survival was 21.3 months in the study cohort. • This combination represents a potential paradigm shift for patients with limited treatment options for advanced endometrial cancer.

FDA Approves Tevimbra Plus Chemotherapy for First-Line Treatment of Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression. • The approval was based on the RATIONALE-305 trial, which showed a median overall survival of 15.0 months with Tevimbra plus chemotherapy compared to 12.9 months with chemotherapy alone. • Common side effects of Tevimbra in combination with chemotherapy include decreased blood cell counts, fatigue, and gastrointestinal issues, but the combination offers a manageable safety profile. • This approval marks the second for Tevimbra in 2024, highlighting its potential to address critical needs in oncology and providing a valuable new treatment option.

Immunotherapy Plus Chemoradiation Improves Outcomes in Esophageal Cancer

6 months ago

• A phase II trial shows that adding immunotherapy to chemoradiation can improve outcomes for esophageal cancer patients. • The triple combination of radiation, chemotherapy, and immunotherapy made tumors more amenable to surgery. • Patients who underwent surgery after the triple therapy experienced significantly longer survival rates. • A phase III trial (SCIENCE) showed that adding sintilimab to neoadjuvant chemoradiotherapy improved pathological complete response rates.

Drug Development Updates