Clinical Trial News

The SPLASH trial evaluates Lutetium-177-PNT2002 in metastatic castration-resistant prostate cancer patients progressing on ARPI therapy, showing significant improvement in radiographic progression-free survival with a hazard ratio of 0.71. Dr. Sartor highlights the favorable safety profile and efficacy, including higher objective response rates and PSA responses, but notes the high crossover rate (84.6%) from the control arm to Lutetium therapy, potentially affecting overall survival results. The unique dosing schedule of this agent, compared to other Lutetium-177 therapies, is discussed for its potential advantages in reduced toxicity. The evolving landscape of radiopharmaceuticals, including dose optimization, new isotopes, and combination therapies, is emphasized for increased treatment options.

IMCI Pharmaceuticals, an Israeli startup, has developed a method to create nanoparticles from cannabis for more effective medical delivery, reducing the need for smoking. The company's iCann platform offers three products: a fast-acting sublingual pill, a long-lasting oral tablet, and a swallowed pill, all designed for chronic ailments. IMCI plans to conduct human trials in Jerusalem next year and aims to bring its first product to market within a year.

Study met primary endpoint, significant improvement in radiographic progression-free survival. Overall Response Rate was 38.1% vs. 12.0% for ARPI switch arm, including 9.3% Complete Responses.

MacroGenics presented updated efficacy and safety results from the TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo) at ESMO, showing encouraging antitumor activity with a 6-month landmark rPFS rate and ORR. Patients remained on vobra duo through a median of 6 doses, extending treatment duration compared to Phase 1. The company expects mature median rPFS data by early 2025 and will host an investor call on September 16, 2024.

Akeso presented efficacy data for its PD-1/VEGF bispecific antibody, ivonescimab, with or without ligufalimab, combined with FOLFOXIRI as a first-line treatment for metastatic colorectal cancer at the 2024 ESMO Conference. Both regimens showed high anti-tumor activity and effective disease control for MSS/pMMR mCRC, with ivonescimab plus ligufalimab demonstrating superior efficacy.

FDA approves Roche's Ocrevus Zunovo for MS and Eli Lilly's Ebglyss for eczema. Walgreens to pay $106.8 million for fraudulent billing. WHO supports Bavarian Nordic's mpox vaccine distribution in low-income countries.

Retifanlimab plus carboplatin and paclitaxel improved progression-free survival for recurrent or metastatic SCAC, according to the phase 3 POD1UM-303/InterAACT 2 study.

Apple's AirPods Pro 2 granted FDA approval for over-the-counter hearing aid software, enabling them to function as hearing devices for users with mild to moderate hearing loss. The feature involves a hearing test on iPhone, creating a personalized sound profile. Apple also plans to introduce this feature in future AirPods models.

Early switch to atezolizumab after vemurafenib plus cobimetinib showed improved OS at 4 and 5 years for BRAF V600-positive melanoma patients, though not statistically significant. Rapid progression after early switch to immune checkpoint inhibition was observed in many patients. Median OS was 40.2 months in continuous targeted therapy vs 49.6 months in atezolizumab group. No subgroups benefited from targeted therapy run-in.

Perioperative nivolumab showed a median event-free survival (EFS) of 40.1 months vs 17.0 months with placebo in resectable non–small cell lung cancer (NSCLC) patients, according to the phase 3 CheckMate 77T study. The study also found significant EFS benefits for patients with and without pathologic complete response (pCR), and higher ctDNA clearance rates with nivolumab.