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Based on OS data from the phase 3 ENGOT-OV16/NOVA trial, the FDA has requested niraparib to have restricted use as a second-line maintenance therapy for patients without germline BRCA mutations.

Toni K. Choueiri, MD, discusses a key next step for using pembrolizumab in the treatment of renal cell carcinoma.

Retrospective analysis of a phase 2 trial indicated that tivozanib demonstrated efficacy and tolerability in the subset of patients who had non-clear cell histologies of renal cell carcinoma.

The impressive POSEIDON clinical trial results have led to the FDA approval of tremelimumab in combination with durvalumab and platinum-based chemotherapy for the treatment of metastatic non–small cell lung cancer.

Based on results from the phase 3 AHOD1331 trial, the FDA has approved brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients with high-risk classical Hodgkin lymphoma.

Matthew P. Goetz, MD, discusses the background of the ELAINE-1 study examining lasofoxifene in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer harboring estrogen receptor 1 mutations.

The FDA has advised ADC Therapeutics that a randomized phase 3 confirmatory study is needed to support a future FDA approval for camidanlumab tesirine as treatment of relapsed or refractory Hodgkin lymphoma.

Part 2 of the NOVA-II phase 2 trial evaluating OQL011 has enrolled the first patient with cancer with VEGFR inhibitor-associated hand-foot skin reaction.

Results from a phase 3 study show that the continuous maintenance therapy of enzalutamide reduces the risk of disease progression in certain patients with metastatic castration resistant prostate cancer.

Ipsen plans to seek FDA approval for the NALIRIFOX regimen based on positive results from the phase 3 NAPOLI 3 clinical trial.

A first-in-human study investigating the safety and immunogenicity of amplivant adjuvant and human papillomavirus type 16 synthetic long peptides demonstrated highly favorable safety and tolerability when used as an intradermal therapeutic vaccine.

In an interview with Targeted Oncology, Tycel Phillips, MD, discussed the many treatment options available and those that are being examined for patients with mantle cell lymphoma in the second-line setting.

Results from bemarituzumab in the phase 2 FIGHT study hint that FGFR2b may be a new target of interest in gastric cancer.

Alexey Danilov, MD, PhD, discusses some targeted therapies being investigated in the relapsed/refractory chronic lymphocytic leukemia space.

Positive Study 16113 results have led the FDA to grant approval to to cemiplimab in combination with chemotherapy for the treatment of patients with advanced non–small cell lung cancer.

In an interview with Targeted Oncology, Ursula A. Matulonis, MD, discussed the pooled analysis of 3 studies which examined single agent mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer.

Treatment with pelareorep plus atezolizumab in patients with advanced/metastatic pancreatic ductal adenocarcinoma led to an overall response rate nearly triple than the average which were previously reported in historical control trials.

Patients with endometrial cancer were more likely to have cardiovascular disease before and after their cancer diagnosis compared with patients without cancer.

Five-year data from the phase 3 KEYNOTE-042 shows that patients with non–small cell lung cancer without EGFR/ALK alterations continue to elicit durable benefit with pembrolizumab monotherapy vs chemotherapy.

Chad Tang, MD, The University of Texas MD Anderson Cancer Center, discusses the design of the randomized, phase 2, basket EXTEND trial.

Retrospective real-world evidence shows that patients who relapse after B-cell maturation antigen chimeric antigen receptor T-cell therapy may have multiple treatment options, including salvage therapy and T-cell engagers.

The interim analysis of the phase 2 MANTRA-2 trial of milademetan, an MDM2 inhibitor, has demonstrated promising safety and activity in patients with advanced solid tumors. The trial will continue enrolling patients.

In an interview with Targeted Oncology, Susana K. Banerjee, PhD, further discussed the updated results of the MEDIOLA trial and the implications of these findings.

Updated data from the phase 1/2 AUGMENT trial led to a 30% complete remission rate and an overall response rate of 53% with SNDX-5613 when used in patients with relapsed/refractory acute leukemias.

Jonathan E. Rosenberg, MD, discusses what has been previously shown with enfortumab vedotin for patients with locally advanced metastatic urothelial cancer.

By combining telisotuzumab vedotin with erlotinib for patients with c-MET protein expressing non–small cell lung cancer, researchers saw promising early antitumor activity.

Despite halting the development of SRF388, the developer announces positive phase 1 efficacy and progress in a phase 2 study of SRF388 in combination with pembrolizumab.

The phase 1 study of lintuzumab-Ac225 combined with the CLAG-M regimen in acute myeloid leukemia demonstrated positive response rates, including an overall survival rate of 53% at 1-year and 32% at 2-years.

A breakthrough therapy designation has been granted by the FDA to elranatamab for relapsed/refractory multiple myeloma.