PC14586 Shows Preliminary Activity, Safety in p53 Y220C–Mutant Solid Tumors
July 28th 2022The first-in-class p53 reactivator, PC14586, induced a response in approximately 1 of 4 patients with advanced solid tumors harboring p53 Y220C mutations and showcased an acceptable safety profile consisting primarily of grade 1 and 2 events.
Bomedemstat Demonstrates Early Promise in Advanced Myelofibrosis
July 26th 2022Single-agent bomedemstat was found to improve symptom scores, bone marrow fibrosis, spleen volumes, and anemia in patients with advanced myelofibrosis, according to findings from the phase 1/2 IMG-7289-CTP-102 trial (NCT03136185) presented during the 2022 EHA Congress.
Selinexor/Ruxolitinib Combo Shows Early Activity, Tolerability in Treatment-Naïve Myelofibrosis
July 25th 2022A combination comprised of selinexor (Xpovio) and ruxolitinib (Jakafi) induced rapid spleen responses at week 12 and showcased a manageable toxicity profile in patients with treatment-naïve myelofibrosis.
Eltanexor Gets FDA Fast Track Status and Orphan Medicinal Product Designation in Europe for MDS
July 21st 2022Eltanexor has been granted a fast track designation from the FDA and an orphan medicinal product designation from the European Commission for use as a potential therapeutic option in patients with myelodysplastic syndromes.
FDA Grants Fast Track and Rare Pediatric Disease Designations to WU-CART-007 in R/R T-ALL and LBL
July 21st 2022The FDA has granted fast track and rare pediatric disease designations to the CAR T-cell therapy WU-CART-007 for the treatment of patients with relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.
Pirtobrutinib Demonstrates Encouraging Efficacy, Favorable Safety in Previously Treated CLL/SLL
July 14th 2022Pirtobrutinib continued to produce promising responses in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, irrespective of BTK C481 mutation status, reason for prior BTK inhibitor discontinuation, or other classes of previous therapy received.
Ibrutinib/Obinutuzumab Combo Elicits Durable Responses in Relapsed/Refractory CLL
July 13th 2022Findings from a phase 1b trial showed that the addition of obinutuzumab to ibrutinib produced a complete response rate that compared favorably with what has historically been observed with ibrutinib monotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.
FOR46 Shows Early Antitumor Activity in Metastatic Castration-Resistant Prostate Cancer
July 12th 2022The CD46-targeted antibody-drug conjugate FOR46 demonstrated encouraging evidence of antitumor activity in patients with metastatic castration-resistant prostate cancer with a safety profile that proved to be similar to other monomethyl auristatin E–based ADCs, according to data from a phase 1a/1b trial.
FDA Grants Fast Track Designation to Belzupacap Sarotalocan for Non–Muscle Invasive Bladder Cancer
July 7th 2022The FDA has granted a fast track designation to belzupacap sarotalocan for the treatment of patients with non–muscle invasive bladder cancer, representing the first virus-like drug conjugate candidate therapy from Aura Biosciences, Inc., the drug developer.