Camrelizumab

In September 2024, the FDA approved multiple oncology treatments, including subcutaneous atezolizumab, ribociclib for early breast cancer, isatuximab for multiple myeloma, selpercatinib for medullary thyroid cancer, and osimertinib for advanced NSCLC. Other approvals included OBX-115 for melanoma, FoundationOne CDx and Liquid CDx for prostate cancer, subcutaneous bortezomib, IBI363 for melanoma, 212Pb VMT01 for melanoma, ABD-147 for neuroendocrine carcinoma, certepetide for cholangiocarcinoma, tebapivat for myelodysplastic syndromes, elraglusib for soft tissue sarcoma, VNX-101 for leukemia, P-BCMA-ALLO1 for multiple myeloma, adjuvant ribociclib for breast cancer, pembrolizumab for mesothelioma, ICT01 for leukemia, CF33-hNIS for cholangiocarcinoma, trastuzumab-strf, amivantamab for NSCLC, CD-001, isatuximab for multiple myeloma, EO-3021 for gastric cancer, camrelizumab for HCC, LP-184 for rare pediatric tumors, osimertinib for NSCLC, and selpercatinib for medullary thyroid cancer.

ODAC voted against PD-1 inhibitors in HER2-, MSS gastric/GEJ adenocarcinoma with PD-L1 < 1. Camrelizumab plus rivoceranib NDA resubmitted for unresectable HCC. FDA approved osimertinib for locally advanced, unresectable EGFR+ NSCLC after chemoradiation. ODAC also voted against anti-PD-1 therapy in metastatic/unresectable ESCC with PD-L1 < 1. FDA granted selpercatinib approval for RET fusion+ medullary thyroid cancer.

Elevar Therapeutics resubmitted an NDA to the FDA for camrelizumab plus rivoceranib in unresectable HCC, following a CRL addressing manufacturing issues. The resubmission is supported by phase 3 CARES-310 trial data showing improved OS and PFS compared to sorafenib, with no new safety signals.

The FDA received a resubmitted NDA for camrelizumab plus rivoceranib for unresectable HCC, supported by phase 3 CARES-310 trial data. The original NDA faced a CRL in May 2024 due to GMP deficiencies at the Hengrui Pharma facility. The resubmission was facilitated by a Type A meeting where FDA confirmed adequacy of responses, allowing resubmission without delay. The combination showed promising efficacy, with the longest median OS in a global phase 3 trial for unresectable HCC.

Elevar Therapeutics resubmits NDA to FDA for rivoceranib plus camrelizumab as first-line treatment for unresectable hepatocellular carcinoma, supported by CARES-310 study showing 23.8 months median overall survival.

The FDA has received a resubmitted NDA for camrelizumab plus rivoceranib as a frontline treatment for unresectable hepatocellular carcinoma (HCC), following a previous CRL citing manufacturing and inspection issues. The resubmission is supported by the phase 3 CARES-310 trial, which demonstrated a median overall survival of 23.8 months with the combination therapy versus 15.2 months with sorafenib. The combination showed a 26.8% overall response rate and a favorable safety profile, with no new safety signals noted.

Elevar Therapeutics resubmits NDA to FDA for rivoceranib (oral VEGF-TKI) combined with camrelizumab (PD-1 inhibitor) as first-line treatment for unresectable hepatocellular carcinoma (uHCC), following FDA's May 2024 Complete Response Letter citing GMP deficiencies and incomplete BIMO inspections. The resubmission is supported by the Phase 3 CARES-310 study, which reported the longest median overall survival for any treatment in a global Phase 3 trial for uHCC.

HLB resubmitted its liver cancer drug candidate rivoceranib to the FDA, combined with camrelizumab, after addressing CMC issues. The submission includes patient survival data from ASCO 2024, with a decision expected by March 2025. Rivoceranib plus camrelizumab showed superior efficacy to sorafenib in a phase 3 trial, though it had a higher rate of adverse events.

The FDA issued a CRL requesting additional CMC info on camrelizumab, prompting Elevar Therapeutics and Hansoh Pharmaceutical to address concerns. They submitted a re-evaluation application for liver cancer drug approval, including mOS data from ASCO 2024, four months after the CRL. The FDA will set a review period, with potential approval by November 20 or March 20. The submission focused solely on CMC, with no comments on efficacy or safety.

The Phase III APOLLO trial presented at ESMO 2024 showed Chia Tai Tianqing's Focus V (anlotinib) plus Akeso's penpulimab significantly improved progression-free survival (PFS) and overall survival (OS) in first-line advanced hepatocellular carcinoma (aHCC) compared to sorafenib, with a manageable safety profile. This contrasts with the failure of Merck's Keytruda in the LEAP-002 trial. Elevar Therapeutic's PD-1 IO camrelizumab and TKI rivoceranib also showed benefits in the CARES-310 trial but with more adverse events. Despite these results, Roche's Tecentriq with bevacizumab remains the first-line standard of care in aHCC, predicted to generate $980m in sales by 2029.