Jordyn Sava

The first orphan drug designation from the FDA has been received by FORE Biotherapeutics and for the FORE8394 program for patients with primary brain and central nervous system malignancies.

In an interview with Targeted Oncology, Guenther Koehne, MD, PhD, provided an overview of The Summit of Americas on Immunotherapies for Hematologic Malignancies and some of the recent and exciting advances being seen in the hematology space.

ISB 1442, a 2+1 biparatopic bispecific antibody that has CD38 and CD47 targeting domains, has received an orphan drug designation from the FDA and is being assessed in a phase 1/2 clinical trial for patients with multiple myeloma.

Ripretinib will be evaluated in a phase 3 trial for patients with gastrointestinal stromal tumor after being added to the NCCN guidelines and receiving 2 breakthrough therapy designations from the FDA.

At a prespecified analysis of the CARTITUDE-1 trial with a median follow-up of approximately 28 months, treatment with cilta-cel continued to elicit positive responses and maintained a favorable risk/benefit profile for patients with multiple myeloma.

Two studies of patritumab deruxtecan in patients with EGFR-mutated metastatic non–small cell lung cancer and HER3-expressing metastatic breast cancer revealed promising overall response, disease control, progression-free survival rates, and more.

In an interview with Targeted Oncology, Hitomi Hosoya, MD, discussed the potential use of ctDNA in the myeloma space, including its ability to sequence BCMA-targeted therapies and reduce the need for bone marrow exams.

The phase 3 KeyVibe-002 trial of pembrolizumab and vibostolimab did not meet its primary end point of progression-free survival and was numerically less effective than docetaxel in patients with non–small cell lung cancer

The combination of CDK9 plus BTK inhibition has already demonstrated synergistic clinical efficacy vs BTK inhibition alone. Now, a clinical trial collaboration will evaluate PRT2527 and zanubrutinib for patients with hematologic malignancies.

A case report published in The Journal of the National Comprehensive Cancer Center highlights the importance of being mindful of unusual adverse events associated with BRAF/MEK inhibition for patients with BRAF-mutated non–small cell lung cancer.

In an interview with Targeted Oncology, Yuri E. Nikiforov, MD, PhD, discussed what led to the reclassification of NIFTP and the incidence of thyroid cancer in patients.

Findings from the phase 2 Study CDRB436G2201 trial have led the FDA to approve dabrafenib combined with trametinib for pediatric patients with BRAF V600E-mutated low-grade glioma who require systemic therapy.

In an interview with Targeted Oncology, Aime T. Franco, PhD, discussed the molecular landscape of pediatric patients with thyroid cancer and the presentation she gave at the 91st Annual Meeting of the American Thyroid Association.

The newly approved supplemental new drug application for Illuccix by the FDA will enable patients with prostate cancer to be identified and selected for radioligand therapy.

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.

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.