Chris Ryan

Dan Pollyea, MD, MS, discussed the difficulties in developing new agents for the treatment of high-risk MDS, the objective of the ENHANCE trial, and the potential for other therapies to emerge in the treatment paradigm.

The addition of SHR3680 to androgen deprivation therapy significantly improved radiographic progression-free survival and overall survival compared with bicalutamide plus ADT in patients with high-volume, metastatic hormone-sensitive prostate cancer, according to data from the phase 3 CHART trial.

Maintenance therapy with niraparib significantly improved progression-free survival compared with placebo in Chinese patients with newly diagnosed advanced ovarian cancer who achieved a complete response or partial response to first-line chemotherapy.

The addition of zilovertamab to ibrutinib will be compared with ibrutinib plus placebo in patients with relapsed/refractory mantle cell lymphoma as part of the phase 3 ZILO-301 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of teclistamab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment.

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

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 Philippine FDA has granted approval to alpelisib in combination with fulvestrant for the treatment of patients with PIK3CA-mutated, HR-positive, HER2-negative advanced or metastatic breast cancer.

The European Medicines Agency has validated the marketing authorization application for trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic breast cancer.

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

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 FDA has granted a fast track designation to abelacimab for the treatment of thrombosis associated with cancer.

The addition of cabozantinib to nivolumab and ipilimumab generated a significant improvement in progression-free survival vs nivolumab/ipilimumab alone as a first-line treatment for patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma, meeting the primary end point of the phase 3 COSMIC-313 trial.

The phase 2 CP-MGA271-06 trial closed early following an internal review of safety data of enoblituzumab plus retifanlimab or tebotelimab as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.

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

The addition of belantamab mafodotin-blmf to lenalidomide and dexamethasone generated responses with acceptable safety in patients with newly diagnosed multiple myeloma who were ineligible to undergo autologous stem cell transplant.

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.

Praluzatamab ravtansine achieved a promising overall response rate in patients with advanced hormone receptor–positive, HER2-negative breast cancer.

The addition of tislelizumab to nab-paclitaxel demonstrated efficacy and safety in patients with high-risk non–muscle invasive bladder cancer.

The FDA has warned that treatment with duvelisib has shown a possible increased risk of death and serious adverse effects compared with ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.

Philip A. Philip, MD, PhD, FRCP, discusses unmet needs for patients with pancreatic cancer, emerging targets and agents in the space, and his hopes for future developments in the field.

Socazolimab produced encouraging response rates with an acceptable safety profile in patients with recurrent or metastatic cervical cancer, irrespective of PD-L1 status, according to findings from the dose-expansion portion of a phase 1 trial.

The European Commission has granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory follicular lymphoma after 3 or more prior lines of systemic therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of trastuzumab deruxtecan monotherapy for patients with metastatic HER2-positive breast cancer who have received at least 1 prior anti–HER2-based regimen.

Adjuvant treatment with TX05 resulted in a similar disease-free survival benefit to that of trastuzumab in patients with early-stage HER2-positive breast cancer.

The European Commission has approved pembrolizumab for adjuvant treatment of adult and adolescent patients 12 years and older with stage IIB or IIC melanoma who have undergone a complete resection.

The CAR T-cell therapy ciltacabtagene autoleucel generated a high response rate in patients with multiple myeloma who experienced early clinical relapse or failure to initial therapy.

Sikander Ailawadhi, MD, discusses early efficacy observed with iopofosine I-131, the rationale of investigating the agent in the CLOVER WaM trial in patients with Waldenström macroglobulinemia, and how the radiotherapeutic could affect the treatment paradigm.

The European Medicines Agency's Committee for Medicinal Products for Human Use has unanimously recommended full marketing authorization approval of melphalan flufenamide for patients with triple-class refractory multiple myeloma.

The FDA has granted an orphan drug designation to VBI-1901, a novel cancer immunotherapeutic vaccine candidate, as a potential therapeutic option for patients with glioblastoma.