Camrelizumab

Two trials of neoadjuvant immunotherapy for TNBC showed mixed efficacy signals. NSABP B-59/GBG-96-GeparDouze found no EFS improvement with atezolizumab despite higher pCR. CamRelief trial showed significant pCR improvement with camrelizumab but no survival endpoint advantages. Both trials highlighted the need for further research on biomarkers for patient selection.

OncLive's OncFive highlights top 5 oncology stories: 1) Acalabrutinib/Venetoclax combo improves PFS in frontline CLL. 2) Daratumumab boosts PFS and extends OS in smoldering myeloma. 3) Imlunestrant with or without abemaciclib improves PFS in ESR1+, ER+/HER2- advanced breast cancer. 4) Camrelizumab/chemo boosts pCR in early or locally advanced TNBC. 5) FDA grants breakthrough therapy designation to Dato-DXd for EGFR+ NSCLC.

Treatment with camrelizumab, rivoceranib, and chemotherapy (SOXRC) showed better pre- and postsurgical responses in advanced gastric cancer compared to chemotherapy alone (SOX). The phase 3 DRAGON IV/CAP 05 study reported pathologic complete response rates of 18.3% vs. 5% and major pathologic response rates of 51.1% vs. 37.8% in the SOXRC and SOX groups, respectively. The study suggests an early signal of efficacy for combined PD-1/VEGFR inhibition plus chemotherapy, though not yet ready for routine use.

Neoadjuvant camrelizumab plus chemotherapy significantly improved pathologic complete response (pCR) rates over chemotherapy alone in early or locally advanced triple-negative breast cancer (TNBC), with a 12.2% difference (95% CI, 3.3%-21.2%; 1-sided P = .0038). The phase 3 CamRelief study also showed a trend toward improved survival, supporting camrelizumab plus chemotherapy as a potential new neoadjuvant therapeutic option for TNBC.

The phase 3 CamRelief study showed a 56.8% pathologic complete response rate for camrelizumab plus chemo vs 44.7% for chemo alone in early or locally advanced TNBC, with consistent benefits across subgroups. Early survival trends also favored the camrelizumab regimen.

Camrelizumab plus intensive chemotherapy in neoadjuvant setting improved pathologic complete response (pCR) rates vs chemotherapy alone in early or locally advanced triple-negative breast cancer (TNBC), with a 12.2% difference (56.8% vs 44.7%). Early trends in survival outcomes also favored the camrelizumab regimen.

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Richard Kim, MD, discusses the positive phase 3 CARES-310 trial evaluating rivoceranib plus camrelizumab for first-line HCC treatment, with updated data showing improved survival vs sorafenib. The FDA accepted the NDA resubmission in 2024, anticipating approval once manufacturing issues are resolved, potentially offering a new first-line option for HCC next year.

Cohorts A, B, and C were constructed for a study on treatment efficacy, safety, and pharmacokinetics of anti-PD-1 monoclonal antibody BGB-A317 in patients with various cancers. Ethics approval was obtained for each cohort, and data was de-identified. Multi-slice helical CT scans were used for image processing, with raw DICOM series converted to NIFTI format and normalized. Ground truth 3D segmentation was blindly performed by oncologists, with intra-rater variability assessed. A mapping function was designed to transform tumor volume changes into response outcome probabilities. The RECORD architecture, involving tumor segmentation and deformable registration, was implemented for treatment response classification. Statistical analyses included AUROC, F1-score, and concordance index for treatment outcome evaluations.

October 2024 saw significant FDA actions in oncology, including priority reviews for T-DXd in HER2-low/ultra-low breast cancer, acalabrutinib for frontline mantle cell lymphoma, and approvals for nivolumab plus chemotherapy in operable NSCLC, Cologuard Plus for CRC screening, and zolbetuximab for HER2-negative gastric cancer. Other notable actions included fast track designations, orphan drug designations, and expanded approvals for various cancer treatments.