Merck, Inc.

Immutep initiates TACTI-004 Phase III trial for 1L metastatic NSCLC, evaluating eftilagimod alfa with KEYTRUDA and chemotherapy. First regulatory approval in Australia, with global trial in over 25 countries expected to enroll first patient in Q1 2025.

Immutep Limited announces the initiation of the TACTI-004 Phase III trial for first-line metastatic non-small cell lung cancer, marking its transformation into a Phase III company. The trial will evaluate eftilagimod alfa in combination with KEYTRUDA and chemotherapy, aiming to establish a new standard of care. Enrollment is expected in Q1 2025.

Insomnia market report forecasts growth from 2020 to 2034, driven by increasing prevalence, awareness, and emerging therapies like Seltorexant and TS-142. Challenges include high treatment costs and patient non-compliance, with unmet needs for long-term solutions with minimal side effects.

The FDA granted breakthrough therapy designation to sacituzumab tirumotecan (sac-TMT) for treating advanced or metastatic nonsquamous NSCLC with EGFR mutations (exon 19 deletion or exon 21 L858R) that progressed after TKI and platinum-based chemotherapy. This decision is based on phase 2 expansion cohort data from a phase 1/2 study. Sac-TMT is an investigational TROP2-directed ADC, currently undergoing phase 3 trials in various solid tumors, including NSCLC (TroFuse-004 and TroFuse-009).

The MOVe-NOW study will test a new LAGEVRIO formulation with smaller tablets, aiming to prevent severe COVID-19 outcomes. LAGEVRIO is authorized in several countries, including the U.S., for treating certain COVID-19 cases. The trial includes concomitant remdesivir use and evaluates efficacy, safety, and long-term COVID-19 effects.

The phase III European Network of Gynaecological Oncological Trial-en9/LEAP-001 study, published in the Journal of Clinical Oncology by Marth et al., found no significant differences in progression-free or overall survival with first-line lenvatinib/pembrolizumab vs chemotherapy in patients with advanced endometrial cancer. The study involved 842 patients with stage III to IV or recurrent disease, randomly assigned to receive lenvatinib/pembrolizumab or paclitaxel/carboplatin. Median progression-free survival was 9.6 months vs 10.2 months, and median overall survival was 30.9 months vs 29.4 months, with no statistical criteria for noninferiority met. Grade ≥ 3 treatment-related adverse events occurred in 79% vs 67% of patients, with discontinuation due to adverse events in 39% vs 17%.

Formycon reports nine-month results for 2024, highlighting product approvals for FYB202 in the USA and Europe, the start of clinical development for Keytruda® biosimilar FYB206, and the initiation of FYB210 development. Financial results reflect successful business performance, confirming guidance.

Hanmi presented BH3120's clinical progress at SITC, revealing no dose-limiting toxicity in Phase 1 trials. BH3120, a dual-targeting anticancer drug, is being tested in combination with KEYTRUDA for advanced solid tumors, with full-scale development expected in early 2025.

DelveInsight's report on Nonalcoholic Steatohepatitis (NASH) provides insights into historical and forecasted epidemiology, market trends, current treatment practices, emerging drugs, and market size from 2019 to 2032 in the United States, EU5, and Japan. Key companies and therapies in the NASH market are highlighted, including recent developments like Aligos Therapeutics' Phase 1 data presentation.