Preclinical and phase 1/2a data evaluating the safety and tolerability of EP0042 in patients with relapsed or refractory acute myeloid leukemia has led the FDA to grant an orphan drug designation to the agent.
Jordyn Sava
Jordyn Sava is an editor for Targeted Oncology.
Articles by Jordyn Sava
Promising findings from the phase 2 ELAINE-1 and ELAINE-2 trials have led to the start of a phase 3 study where investigators will evaluate lasofoxifene and abemaciclib as a treatment for patients with ER-positive/HER2-negative breast cancer and an ESR1 mutation.
As a result of the FDA’s clinical hold on the phase 1 trial, no patients with HER2-positive recurrent or metastatic solid tumors will be enrolled or dosed with XMT-2056.
CYAD-01, an autologous CAR T-cell therapy, was tolerable and showed activity in patients with acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma.
The phase 2/3 KEYNOTE-483 trial of pembrolizumab plus chemotherapy for patients with mesothelioma elicited improvements in overall survival and showed consistent safety with previously reported data.
A phase 1b/2a trial is investigating the combination of bemcentinib with pembrolizumab and doublet chemotherapy in patients with first-line non–small cell lung cancer that harbors STK11 mutations.
A comprehensive analytical data package and pharmacokinetic, pharmacodynamic, and immunogenicity study has led the FDA to approve the pegfilgrastim biosimilar pegfilgrastim-cbqv for patients with cancer.
Soligenix has requested a Type A meeting with the FDA to get clarity around the item needed to complete the new drug application of SGX301 for patients with early-stage cutaneous T-cell lymphoma.
Findings from the patient-reported outcomes analysis of the phase 3 KEYNOTE-826 trial support the benefit of pembrolizumab in patients with recurrent, persistent, or metastatic cervical cancer.
In a vote of 11 to 2, the FDA's Oncologic Drugs Advisory Committee voted for the benefit/risk profile of polatuzumab vedotin in combination with R-CHP, based on findings from the confirmatory POLARIX trial.
Alexander Spira, MD, PhD, FACP, discusses the combination of amivantamab-vmjw and lazertinib for patients with relapsed or refractory EGFR-mutant non–small cell lung cancer and findings presented at the 2022 IASLC World Conference on Lung Cancer.
Findings from a phase 3 clinical trial, including data from high-risk children given remestemcel-L, led the FDA to accept the biologics license application of the therapy.
During a live Twitter Spaces event hosted by Targeted Oncology, Naveen Pemmaraju, MD, explained key abstracts from ASH 2022 and how these data have influenced recent approvals in the hematology field.
JWATM214, an autologous T-cell immunotherapy candidate drug targeting GPC-3 for patients with advanced hepatocellular carcinoma, is now being investigated in a phase 1 trial.
The phase 3 KEYNOTE-641 of pembrolizumab, enzalutamide, and androgen deprivation therapy has been discontinued, and overall survival rates in the phase KEYNOTE-789 study of pembrolizumab, pemetrexed, platinum-based chemotherapy did not meet statistical significance.
Data from the second interim analysis of the phase 3 MAGNITUDE study showed that the addition of niraparib to abiraterone acetate and prednisone prolonged survival for patients with metastatic castration-resistant prostate cancer with BRCA mutations.
In an interview with Targeted Oncology, Zahra Mahmoudjafari, PharmD, BCOP, discussed the post hoc analysis from the REACH2 trial and highlighted the key takeaways.
Efficacy findings from CheckMate-76 have led the FDA to accept the supplemental biologics license application and the EMA to validate the type II variation marketing authorization application for nivolumab alone in stage IIB or IIC melanoma.
Yann-Alexandre Vano, MD, explains the methods and design of the phase 2 BIONIKK trial for patients with renal cell carcinoma.
The phase 3 PhALLCON trial showed a trend toward event-free survival in patients with Philadelphia chromosome positive acute lymphoblastic leukemia when treated with ponatinib compared with imatinib.
Based on the FDA’s review of a new drug application, a phase 2 study will evaluate the safety and efficacy of azeliragon for patients with glioblastoma.
Data from the phase 3 DeFi trial showed that nirogacestat led to a 71% reduction in the risk of disease progression compared with placebo for adult patients with desmoid tumors. Now, the FDA has granted a priority review to the new drug application for nirogacestat.
Experts addressed ARX788 for patients with HER2-positive breast cancer, and a data update from the update for APEX-01 evaluating ARX517 in patients with prostate cancer was provided during a virtual analyst and investor day.
Encouraging results in melanoma have led experts to explore the gut microbiome in colorectal cancer. The next hot topic in research may be the gut microbiome's role for the prevention, progression, and management of colorectal cancer.
A phase 1 dose-escalation and -expansion clinical trial will evaluate BA3182, a potential anticancer therapy, for patients with advanced adenocarcinoma based on the clearance of an investigational new drug application from the FDA.
In an interview with Targeted Oncology, Lori Muffly, MD, discusses the subanalysis of a phase 1 study of briquilimab plus low-dose total body radiation and fludarabine which was presented at 2023 Tandem Meetings on Transplantation and Cellular Therapy.
The FDA has granted a breakthrough therapy designation to mRNA-4157/V940 based on data from KEYNOTE-942 which showed that the addition of an mRNA vaccine to adjuvant pembrolizumab improved recurrence-free survival following resection of high-risk melanoma.
With the main end points of incidence of severe neutropenia and alopecia not met in the phase 1b trial of ALRN-6924 for patients with p53-mutated breast cancer, Aileron Therapeutics has decided to end the trial.
Results from cohort A of the MagnetisMM–3 trial of erlanatamab for patients with relapsed/refractory multiple myeloma have led the FDA to grant priority review to a biologics license application for the agent in this patient population.
An analysis with longer follow-up of the ZUMA-3 study showed patients with relapsed/refractory B-cell acute lymphoblastic leukemia treated with brexu-cel had a median overall survival of 26 months and a complete response plus CR with incomplete count recovery rate of 71%.