Memorial Sloan Kettering Cancer Center

Nuvalent's NVL-655, a selective and brain-penetrant ALK inhibitor, is detailed in a Cancer Discovery manuscript, addressing limitations of current ALK TKIs in treating ALK-positive NSCLC. Preclinical and preliminary clinical data support NVL-655's potential to overcome resistance and improve tolerability, with ongoing ALKOVE-1 trial enrollment and planned ESMO Congress presentation.

Biomarkers, the unique genetic signature of tumors, help oncologists match patients with the most effective treatment options, transforming cancer care across various tumor types.

Kintara Therapeutics provides corporate and REM-001 clinical study updates, including a merger agreement with TuHURA Biosciences and a special stockholder meeting on September 20, 2024. The REM-001 study for cutaneous metastatic breast cancer has enrolled four of ten needed patients, with no safety issues identified.

IDeate-Lung01 study interim analysis shows ifinatamab deruxtecan (I-DXd) at 12 mg/kg has 54.8% confirmed objective response rate (ORR) in extensive-stage small cell lung cancer (SCLC), significantly higher than 8 mg/kg dose (26.1% ORR). Higher dose also shows better disease control rate and intracranial activity.

A study by Memorial Sloan Kettering Cancer Center found CAR-T therapy does not increase the risk of secondary cancers, contrary to FDA warnings. The research, published in 'Clinical Cancer Research,' analyzed data from 18 clinical trials and seven real-world studies involving over 5,500 patients, showing similar rates of secondary cancers between CAR-T and standard treatments. The study suggests warning labels may need revision.

Pembrolizumab plus chemotherapy showed greater pathologic regression vs placebo in early-stage NSCLC patients, with lower %RVT associated with better EFS. The KEYNOTE-671 trial demonstrated significant improvements in OS, EFS, pCR, and mPR with pembrolizumab. The FDA approved pembrolizumab in 2023 for neoadjuvant and adjuvant treatment of resectable NSCLC.

I-DXd (ifinatamab deruxtecan) showed clinically meaningful responses in pretreated extensive-stage SCLC patients, with a confirmed response rate of 26.1% at 8 mg/kg and 54.8% at 12 mg/kg. The 12 mg/kg dose was selected as optimal for further study.

MSD and Daiichi Sankyo presented interim results from the Ideate-Lung01 trial at WCLC, showing the 12 mg/kg dose of ifinatamab deruxtecan (I-DXd) had a 54.8% overall response rate (ORR) in extensive-stage small cell lung cancer (SCLC) patients, with a disease control rate (DCR) of 90.5%. The higher dose also showed improved progression-free and overall survival. Safety concerns included interstitial lung disease and gastrointestinal toxicities, but no 'great surprises'. The companies have started phase 3 Ideate-Lung02 study.

Ifinatamab deruxtecan (I-DXd) showed improved efficacy in heavily pretreated extensive-stage small cell lung cancer (ES-SCLC) patients, with a 12-mg/kg dose achieving a 54.8% overall response rate (ORR) vs 26.1% for an 8-mg/kg dose. The 12-mg/kg dose also had a 90.5% disease control rate (DCR) and a median duration of response (DOR) of 4.2 months, compared to 7.9 months for the 8-mg/kg dose. Both doses were generally well-tolerated, with gastrointestinal and hematologic toxicities as the primary adverse effects.

Daiichi Sankyo and Merck's ifinatamab deruxtecan shows 54.8% objective response rate at 12 mg/kg in pretreated extensive-stage small cell lung cancer patients, leading to its selection for phase 2 and 3 trials.