Cetrelimab

Siamak Daneshmand, MD, discusses TAR-200 monotherapy safety and tolerability in BCG-unresponsive NMIBC patients, highlighting well-tolerated side effects (mostly grade 1-2) and low discontinuation rates due to side effects (5 out of 85 patients).

Dr. Jacqueline Brown discussed emerging perioperative systemic therapies for muscle invasive bladder cancer at the 2024 SUO annual meeting, highlighting the VESPER trial showing dose dense MVAC improved survival over gemcitabine + cisplatin, and the CheckMate 274 trial demonstrating adjuvant nivolumab's efficacy. Ongoing trials like NIAGARA and ENERGIZE explore chemo-immunotherapy combinations, while novel agents such as enfortumab vedotin and sacituzumab govitecan show promise in the perioperative setting.

XOMA Royalty reports Q3 2024 financials: $7.2M income, FDA approval for Zevra’s MIPLYFFA™ (arimoclomol), $15M royalty monetization with Twist Bioscience, $9.9M cash receipts in Q3, $42.3M YTD.

FDA mandates breast density notification; CAR T-cell therapy linked to secondary cancers; breast cancer survivor creates documentary; piano lessons may alleviate chemotherapy brain fog; Johnson & Johnson halts bladder cancer trial; Merck's Keytruda improves head and neck cancer survival; Pfizer's Talzenna plus Xtandi extends prostate cancer survival; breast cancer treatments accelerate aging biomarkers; 3D-printed breast prosthesis detects tumor recurrence; industry funding for cancer trials raises concerns; Iranian cancer researchers under scrutiny; blood test predicts prostate cancer survival.

Johnson & Johnson halts phase 3 SunRISe-2 trial evaluating TAR-200 and cetrelimab vs chemoradiation for muscle-invasive bladder cancer (MIBC) patients not undergoing radical cystectomy, following an interim analysis. The company remains confident in TAR-200's potential, with ongoing studies and an FDA filing planned for early 2025.

Johnson & Johnson discontinued SunRISe-2 study for TAR-200 in MIBC patients not undergoing radical cystectomy, based on interim analysis showing no superiority to chemoradiation. The company remains confident in TAR-200's potential for bladder cancer treatment.

SunRISe-4 interim analysis: TAR-200 + cetrelimab showed 42% pathologic complete response and 60% pathologic objective response in muscle-invasive bladder cancer patients, compared to 23% and 35% with cetrelimab monotherapy. TAR-200 + cetrelimab had manageable safety, with 13% discontinuations due to adverse events.

TAR-200 plus cetrelimab in neoadjuvant treatment of MIBC showed strong pCR and pOR rates in SunRISe-4 study, with 42% pCR in TAR-200 plus cetrelimab group vs 23% in cetrelimab alone group. The study highlights the benefit of combining intravesical therapy with a systemic immune checkpoint inhibitor in MIBC patients.

At ESMO's annual meeting, Pfizer's ponsegromab showed promise in treating cancer cachexia, helping patients regain weight and improve symptoms. Johnson & Johnson's TAR-200, a chemotherapy-releasing device, demonstrated efficacy in bladder cancer, with 42% of patients showing no cancer evidence. BioNTech and Instil Bio presented early data on drugs targeting PD1 and VEGF, similar to Summit Therapeutics' successful trial. Long-term studies revealed Keytruda's superior survival rates over Yervoy in melanoma patients. Scorpion Therapeutics' STX-478 showed potential as a PI3Ka inhibitor with manageable side effects.

Neoadjuvant TAR-200 plus cetrelimab nearly doubles pathological complete response rate in muscle-invasive bladder cancer patients compared to cetrelimab alone, according to interim data from the SunRISe-4 study presented at ESMO 2024.