The OncFive: Top Oncology Articles for the Week of 11/24

Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.

Here’s what you may have missed this week:

FDA Accepts BLA for Belantamab Mafodotin–Based Combos in R/R Myeloma

The FDA has accepted a biologics license application (BLA) seeking the approval of 2 belantamab mafodotin (Blenrep) in combination with bortezomib (Velcade) and dexamethasone (BVd) and in combination with pomalidomide (Pomalyst) and dexamethasone (BPd), for the treatment of patients with multiple myeloma who have received at least 1 prior line of therapy.

The BLA is based on findings from the phase 3 DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) trials, which evaluated BVd and BPd, respectively. In both studies, the belantamab mafodotin–based combinations led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared standard-of-care triplet regimens in patients with relapsed/refractory multiple myeloma.

The FDA has set a target action date for the BLA of July 23, 2025, under the Prescription Drug User Fee Act.

FDA Approves Oral Solution of Imatinib for Certain Leukemias, Other Cancers

The FDA approved an oral solution of imatinib (Imkeldi) for the treatment of patients with certain forms of leukemia and other types of cancer. After imatinib (Gleevec) was initially approved by the FDA in 2001, the oral solution is also indicated across a range of hematologic malignancies, including for the treatment of select patients with chronic myeloid leukemia, acute lymphoblastic leukemia, systemic mastocytosis, and gastrointestinal stromal tumors.

Capivasertib Plus Abiraterone/ADT Improves rPFS in PTEN-Deficient mHSPC

The addition of capivasertib (Truqap) to abiraterone acetate (Zytiga) and androgen deprivation therapy (ADT) produced a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) vs placebo plus abiraterone and ADT in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC), meeting the primary end point of the phase 3 CAPItello-281 trial (NCT04493853).

Full data from this analysis of the CAPItello-281 trial will be presented at an upcoming medical meeting and shared with global health authorities.

Pancreatic Cancer Awareness Month Brings Attention to Growing Incidence and Treatment Advances

In honor of Pancreatic Cancer Awareness Month, Suneel Kamath, MD, an assistant professor of medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Ohio, took over the OncLive X (Twitter) account to highlight the growing incidence of the disease and ongoing research in the space.

He then sat down for an interview with Onclive, where he detailed the rising number of cases of pancreatic cancer in the United States and discussed continued efforts to bring more targeted therapies to the treatment paradigm.

“Pancreatic cancer awareness is so important. It's a disease that we've made some progress in over the last 20 to 25 years, but it certainly remains a very deadly disease that we need [to devote] a lot more attention to,” Kamath told OncLive.

Tiragolumab Plus Atezolizumab Fails to Meet OS End Point in PD-L1–High NSCLC

First-line treatment with tiragolumab (MTIG7192A) plus atezolizumab (Tecentriq) did not lead to a significant improvement in overall survival (OS) vs atezolizumab monotherapy in patients with PD-L1–high, locally advanced or metastatic non–small cell lung cancer (NSCLC), according to updated results from the final analysis of the phase 3 SKYSCRAPER-01 trial (NCT04294810).