Pipeline Report: July 2022 | articles

The 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.

Nirogacestat plus belantamab mafodotin induced promising responses with manageable safety for patients with relapsed/refractory multiple myeloma.

The addition of pembrolizumab to belantamab mafodotin resulted in a higher overall response rate in patients with relapsed/refractory multiple myeloma than what has been observed with the antibody-drug conjugate alone, according to results from the phase 1/2 DREAMM-4 trial.

Single-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.

A 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.

The FDA has granted an orphan drug designation to DSP-0390 for the treatment of brain cancer.

Eltanexor 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.

The 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.

The FDA has granted an orphan drug designation to NT-I7 for the treatment of patients with glioblastoma multiforme.

Pirtobrutinib 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.

CV-01, Alpheus Medical’s novel sonodynamic therapy delivery platform, has received orphan drug and fast track designations from the FDA for the treatment of patients with recurrent glioblastoma.

Findings 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.

The 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.

The CAR T-cell therapy anbalcabtagene autoleucel generated strong overall response rates in patients with relapsed/refractory large B-cell lymphoma.

The FDA has granted an orphan drug designation to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.

The 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.