BMS Reaches Deal to Codevelop Antibody-Drug Conjugate That Has Shown Promise in Early Trials
December 12th 2023BL-B01D1 is a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate currently being evaluated in the global, multi-center Phase I BL-B01D1-LUNG101 trial in patients with metastatic or unresectable non-small cell lung cancer.
Phase III Trial to Evaluate Novel Individualized Neoantigen Therapy Plus Keytruda in Lung Cancer
December 11th 2023V940 (mRNA-4157) to be evaluated in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.
Phase III Trial of Keytruda Plus Lynparza for NSCLC Stopped Due to Futility
December 7th 2023KEYLYNK-008 trial finds that Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not produce an improved overall survival benefit in patients with metastatic squamous non-small cell lung cancer.
Key Phase III Trial Results Lead to FDA Approval of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria
December 6th 2023Clinical trials demonstrated superiority of Fabhalta to anti-C5s in hemoglobin improvement in the absence of transfusions and transfusion avoidance rate, showing clinically meaningful hemoglobin-level increases without the need for blood transfusions in patients with paroxysmal nocturnal hemoglobinuria.
Blenrep Shows Promise in DREAMM-7 Phase 3 Trial for Relapsed, Refractory Multiple Myeloma
November 30th 2023DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma previously administered at least one prior line of treatment.
FDA Accepts sNDA for Roflumilast Following Promising Trial Results in Atopic Dermatitis
November 30th 2023Arcutis Biotherapeutics’ supplemental new drug application was supported by significant findings from a trio of Phase 3 trials, a Phase 2 dose ranging trial, and a pair of Phase 1 pharmacokinetic studies for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older.