Clinical Trial News

At ESMO Congress 2024, updated Phase III IMbrave050 trial data showed no significant RFS benefit for Tecentriq + Avastin as adjuvant therapy in high-risk HCC, despite earlier interim analysis benefits. Ongoing trials like CheckMate 9DX and KEYNOTE-93 aim to evaluate monotherapy options for HCC, with potential market impacts by 2030.

Pfizer's Phase 2 study of ponsegromab met primary endpoint, showing 5.6% mean body weight increase at highest dose in cancer cachexia patients. Improvements in appetite, cachexia symptoms, physical activity, and muscle mass were observed. Ponsegromab was safe and well-tolerated. Registration-enabling studies are planned for 2025.

AstraZeneca's Imfinzi, used pre- and post-surgery, improved survival rates in bladder cancer patients, reducing death risk by 25% and recurrence by a third, according to the Phase 3 NIAGARA trial results presented at the European Society for Medical Oncology meeting.

A phase 1/2 trial for metastatic kidney cancer showed a novel two-agent regimen at Roswell Park doubled progression-free survival compared to single-agent treatment, with median PFS of 23.3 months versus 11.1 months.

Michael Hofman discusses developing new PSMA PET-CT criteria for prostate cancer progression evaluation, aiming to replace PCWG3 guidelines. Using PRINCE trial data, his team shows high inter-reader agreement and earlier progression detection with PSMA PET-CT, correlating well with overall survival. Hofman emphasizes the need for contrast-enhanced CT in PSMA PET-CT protocols and plans further validation across multiple trials.

Preliminary results from the RC48G001 Study Cohort C show a 75% response rate with disitamab vedotin plus pembrolizumab in HER2-expressing metastatic urothelial cancer, with activity in both HER2-positive and HER2-low tumors. The safety profile differs from enfortumab vedotin plus pembrolizumab, potentially distinguishing it. Dr. Galsky emphasizes the importance of HER2 and FGFR3 biomarker testing in all metastatic urothelial cancer patients, noting 60-80% of tumors express HER2, and highlights the ongoing phase III study comparing this combination to platinum-based chemotherapy.

Pharmac widens access to pembrolizumab (Keytruda) for advanced triple-negative breast cancer, head and neck cancer, colorectal cancer, bladder cancer, and Hodgkin lymphoma, and nivolumab (Opdivo) for kidney cancer. These decisions follow additional government funding in June. 1,000 people will access these treatments in the first year, increasing to 4,500 over five years.

3D Systems and Smith & Nephew announce FDA clearance for total ankle replacement solution, offering personalized ankle replacements with 3D-printed instruments.

RYBREVANT® (amivantamab-vmjw) combined with chemotherapy showed promising antitumor activity in RAS/BRAF wild-type metastatic colorectal cancer patients not previously treated with EGFR therapy, with a median duration of response of 7.4 months. 21% of patients underwent curative-intent surgery, and the safety profile was manageable without new safety signals.

Silk-derived protein-4 (SDP-4) is safe and effective for severe dry eye disease, according to a study in the American Journal of Ophthalmology. Visual art therapy (AVAT) significantly improves mental health outcomes, despite low-quality studies. Excess abdominal fat contributes to chronic musculoskeletal pain, with stronger effects in women. Depemokimab reduces severe asthma exacerbations in phase 3 trials. The Big 3 PBMs—CVS Caremark, Express Scripts, and Optum Rx—utilize various market strategies, prompting calls for federal reform.