AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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.

CHMP recommends daratumumab SC for newly diagnosed multiple myeloma patients eligible for ASCT, supported by PERSEUS study showing 60% reduction in disease progression or death risk with quadruplet therapy.

South Korean researchers found FMTs may enhance immunotherapy efficacy for GI cancer patients, with 46.2% showing benefits. Key bacterial strains like _Prevotella merdae_ improved outcomes, while _Lactobacillus salivarius_ and _Bacteroides plebeius_ had negative impacts. Challenges include efficient production and distribution for widespread adoption.

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.

Elevation Oncology receives FDA Fast Track designation for EO-3021, an ADC targeting Claudin 18.2 in advanced gastric and gastroesophageal junction cancers. The drug showed a 42.8% response rate in Phase 1 trials and plans for further clinical studies. The company faces Nasdaq non-compliance but maintains a strong cash position.

Elevar Therapeutics resubmitted an NDA to the FDA for camrelizumab plus rivoceranib as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), following a CRL due to GMP deficiencies. The Phase 3 CARES-310 study showed a median overall survival of 23.8 months, the longest in a global Phase 3 trial for uHCC.

Peptide-drug conjugates (PDCs) show potential as transformative cancer therapies, offering advantages over antibody-drug conjugates (ADCs) like smaller size, faster internalization, and reduced toxicity. SORT1-targeting PDCs leverage rapid internalization for effective delivery of cytotoxic payloads, demonstrated in preclinical trials with significant tumor regression. Clinical trials of SORT1+ Technology™ platform-based PDCs show promise, including durable disease stabilization and potential for radioisotope conjugates.

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.

Sarclisa approved by FDA as first anti-CD38 therapy in combination with VRd for newly diagnosed multiple myeloma patients not eligible for transplant, based on IMROZ phase 3 study showing significant PFS improvement.

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.