AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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.

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.

Krishnan and Dhakal discuss MajesTEC-1 trial findings on teclistamab for relapsed/refractory multiple myeloma, highlighting efficacy (63% ORR, 46.1% CR) and safety concerns, including infections and AEs. They suggest future treatment shifts towards fixed-duration therapy and individualized dosing based on patient response.

Janssen-Cilag International NV announces CHMP recommendation for DARZALEX subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients eligible for autologous stem-cell transplant. Supported by Phase 3 PERSEUS study data, this aims to establish a new standard of care, enhancing progression-free survival.

Quad countries launch a cancer initiative in the Indo-Pacific, focusing on cervical cancer prevention, detection, and treatment. The initiative aims to improve health infrastructure, expand research collaborations, and support cancer care through various commitments from governments and non-government organizations.

FDA approves Sarclisa (isatuximab) in combination with VRd for newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant, based on IMROZ phase 3 study showing significant PFS improvement. This marks Sarclisa's third indication and first for newly diagnosed patients, reflecting Sanofi's commitment to addressing critical care gaps in multiple myeloma.

Sarclisa approved in the US as the first anti-CD38 therapy in combination with VRd for newly diagnosed multiple myeloma patients not eligible for transplant, significantly improving progression-free survival.