Caroline Seymour

Treatment with the oral, small-molecule Wee1 kinase inhibitor adavosertib was clinically active but not well tolerated in patients with recurrent or persistent uterine serous carcinoma who previously received platinum-based chemotherapy.

The FDA has issued a complete response letter for ruxolitinib extended-release tablets for use once daily in the treatment of patients with certain types of myelofibrosis, polycythemia vera, and graft-vs-host disease.

Acalabrutinib has received conditional approval from the National Medical Products Administration in China for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

The addition of MEDI9253 to sequential or concurrent treatment with durvalumab failed to elicit more than 1 partial response although proving feasible and safe in patients with advanced or metastatic solid tumors, according to findings from a phase 1 trial.

The FDA has granted an orphan drug designation to ISB 1442, the first-in-class biparatopic 2+1 BEAT® bispecific antibody targeting CD38 and CD47 for the treatment of patients with relapsed/refractory multiple myeloma.

The phase 1/2 trial evaluating the addition of Allocetra to standard chemotherapy administered via pressurized intraperitoneal aerosol chemotherapy received regulatory clearance to continue evaluation and launch the dose-escalation cohort in patients with advanced-stage peritoneal metastasis arising from solid tumors following the completion of an interim data review by an Independent Data and Safety Monitoring Board and the Israeli Ministry of Health.

Enzalutamide plus leuprolide demonstrated a statistically significant and clinically meaningful improvement in metastasis-free survival compared with placebo plus leuprolide in patients with nonmetastatic castration-sensitive prostate cancer with a high-risk of biochemical recurrence.

Bellicum Pharmaceuticals has discontinued 2 phase 1/2 trials evaluating the safety and preliminary efficacy of the GoCAR T-cell products BPX-601 and BPX-603 in combination with rimiducid in heavily pretreated patients with advanced solid tumors following an assessment of the risk/benefit profile of the combination of BPX-601 and rimiducid.

Enzalutamide plus androgen deprivation therapy produced a statistically significant improvement in time to prostate-specific antigen progression compared with ADT and placebo in men with metastatic hormone-sensitive prostate cancer, meeting the primary end point of the phase 3 China ARCHES study.

Despite a perhaps overwhelming number of combination regimens available for use in the frontline setting for patients with renal cell carcinoma, treatment decisions can still largely boil down to a patient’s risk status. For second-line therapy, investigators are looking to contemporary trials for guidance.

The FDA has approved nelarabine for injection for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, according to an announcement from Shorla Oncology.

The Center for Drug Evaluation of the China National Medical Products Administration has accepted the biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.

The FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 that data from the phase 3 POLARIX trial support a favorable benefit-risk profile for polatuzumab vedotin-piiq in patients with previously untreated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified.

After settling the debate of which patients with early-stage, hormone receptor–positive breast cancer require chemotherapy in addition to endocrine therapy, investigators have set their sights on determining whether ovarian function suppression can deliver the same effects of chemotherapy and when to recommend abemaciclib and olaparib.

By moving away from adjuvant- to neoadjuvant-based protocols, such as I-SPY, investigators may be better able to develop effective treatments for patients in less time by refining the understanding of who will benefit from therapy, enabling strategies with multiple pathway targets, and testing approaches earlier in the disease course.

The FDA has granted an orphan drug designation to the CEACAM1/5 antibody YB-200 for the treatment of patients with hepatocellular carcinoma.

The addition of pembrolizumab to standard therapies failed to improve survival outcomes in patients with metastatic castration-resistant prostate cancer in the KEYNOTE-641 trial and patients with EGFR-mutated non–small cell lung cancer in the KEYNOTE-789 trial.

Despite treatment with the chemoprotective agent ALRN-6924, patients with p53-mutated breast cancer receiving neoadjuvant or adjuvant therapy with docetaxel, doxorubicin, and cyclophosphamide failed to meet the trial’s primary and secondary end points of duration and incidence of severe neutropenia in cycle 1 and incidence of chemotherapy-induced alopecia, respectively.

Toripalimab plus nab-paclitaxel demonstrated a significant improvement in progression-free survival compared with placebo and nab-paclitaxel in PD-L1–positive patients with stage IV or recurrent/metastatic triple-negative breast cancer.

Atezolizumab monotherapy failed to show an improvement in overall survival compared with placebo plus platinum-based chemotherapy and gemcitabine in patients with untreated locally advanced or metastatic urothelial cancer.

Orca-T produced a 100% overall survival rate in 8 patients with hematologic malignancies who received an allogeneic hematopoietic stem cell transplant with 7/8 non-permissive HLA mismatched donors.

The dual CD19- and CD20-directed, freshly administered CAR T-cell therapy zamtocabtagene autoleucel elicited a high response rate with deepening responses over time in patients with relapsed/refractory diffuse large B-cell lymphoma.

Toripalimab plus gemcitabine and cisplatin demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone as frontline therapy in patients with recurrent or metastatic nasopharyngeal carcinoma.

The FDA has placed a partial clinical hold on the phase 1/2 VELA trial due to visual adverse effects observed in select patients who received the investigational treatment BLU-222.

In an 8 to 5 vote, the FDA’s ODAC voted that data from two proposed single-arm trials will provide adequate means of characterizing the risk-benefit profile of dostarlimab for the treatment of patients with dMMR/MSI-H locally advanced rectal cancer.

The FDA has granted an orphan drug designation to ezurpimtrostat, a PPT-1 inhibitor for the treatment of patients with hepatocellular carcinoma.

Avero Diagnostics has launched AMBLor, a first-of-its-kind laboratory test for the identification of early-stage melanoma at low risk of progression.

Treatment with crovalimab led to disease control through transfusion avoidance and control of hemolysis in patients with paroxysmal nocturnal hemoglobinuria who have not been previously treated with complement inhibitors.

If the FDA’s Oncologic Drugs Advisory Committee meeting held on February 10, 2022, was any indication, the days of applying foreign single country or region data to support regulatory approval are gone; instead, regulatory decisions are headed toward the need for regional consistency through multiregional clinical trials, which could help the United States overcome the persistent underrepresentation of racial and ethnic minorities in drug development.

The FDA has accepted for review a biologics license application for a proposed denosumab biosimilar, according to an announcement from Sandoz, Inc.