Nichole Tucker

The FDA has granted a Breakthrough Therapy designation to MK-6482, a novel HIF-2a inhibitor, as treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma who have non-metastatic tumors that measure less than 3 centimeters in size, unless immediate surgery is needed. The FDA has also granted an Orphan Drug designation to MK-6482 for the treatment of VHL disease alone.

The FDA granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring allosteric HER2 mutation, EGFR mutation, or HER2 exon 20 insertion.

The efficacy of nivolumab, as investigated in an interim analysis of the NORA study was confirmed as treatment of patients with advanced renal cell carcinoma who received 2 more prior lines of therapy.

In an interview with Targeted Oncology, David Reardon, MD, discussed the background and findings for the phase 1/2 clinical trial of INO-5401 and INO-9012 plus cemiplimab in patients with newly diagnosed glioblastoma.

The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab plus ipilimumab under 2 melanoma indications.

In an interview with Targeted Oncology, Bassel El-Rayes, MD, discussed the treatment options for patients with borderline resectable pancreatic cancer. He also discussed sequencing the available agents for borderline resectable pancreatic cancer and the role of circulating tumor DNA in guiding individualized treatment of the disease.

Targeted Oncology reviews trending news online for the week of July 24, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

A Biologics License Application has been submitted to the FDA for inolimomab as a potential treatment for adult patients with steroid-refractory acute graft-versus-host disease, grade II-IV,.

Avelumab in combination with a novel HPV16-targeted vaccine, demonstrated clinical activity as treatment of patients with HPV16-positive recurrent and/or metastatic malignancies.

Ruxolitinib demonstrated a superior overall response rate versus best available treatment at week 24 in patients with steroid-refractory or steroid-dependent chronic graft-versus-host-disease, according to topline results from the phase 3 REACH3 study.

In an interview with Targeted Oncology, Heinz-Josef Lenz, MD, PhD, discussed the history of immune checkpoint inhibition in the metastatic colorectal cancer treatment paradigm.

Neratinib plus capecitabine improved progression-free survival and time to intervention for central nervous system disease in patients with previously treated HER2-positive metastatic breast cancer compared with lapatinib plus capecitabine, results from the phase 3 NALA trial show.

In a presentation during the 2020 Debates and Didactics in Hematology and Oncology conference, Amelia A. Langston, MD, explained the issues with treating patients with relapsed mantle cell lymphoma and how the integration of chimeric antigen receptor T-cell therapy can be a solution to the problem.

Treatment with leronlimab in patients with mild to moderate symptoms of respiratory illness from coronavirus disease 2019 caused fewer serious adverse events when compared with placebo, according to safety results from a phase 2 clinical trial.

In an interview with Targeted Oncology, Ping Chi, MD medical oncologist, Geoffrey Beene Junior Faculty chair, Memorial Sloan Kettering Cancer Center, discussed the phase 2 study of binimetinib in combination with imatinib in patients with untreated advanced GIST.

Enzastaurin, a first-in-class small molecule, has been granted a Fast Track designation by the FDA for the potential treatment of patients with newly diagnosed glioblastoma.

The phase 2 basket arm trial of IDE196 in patients with solid tumors harboring GNAQ or GNA11 hotspot mutations has met its clinical protocol criteria for cohort expansion.

The combination of camrelizumab plus gemcitabine, vinorelbine, and pegylated liposomal doxorubicin demonstrated promising efficacy in patients with relapsed/refractory primary mediastinal B-cell lymphoma. The combination also had a manageable safety profile, according to findings from a phase 2 clinical trial.

The first randomized study of an ATR inhibitor in any malignancy demonstrated the benefit of berzosertib added to gemcitabine as treatment of patients with platinum-resistant high-grade serous ovarian cancer, according to a recently published study.

The national RESPOND study is looking to determine potential underlying factors for the increased burden among African American males compared with American men of European descent and has identified novel variations among the African American population; however, an analysis from the study concluded that genomic alterations in known therapeutic targets show similar frequencies between the 2 racial groups.

In an interview with Targeted Oncology, Ann H. Partridge, MD, MPH, discussed the response to neoadjuvant chemotherapy among patients with ER-positive, HER2-negative breast cancer and how the 21-gene Breast Recurrence Score aids in the prediction of response for this treatment.

In an interview with Targeted Oncology, Joyce F. Liu, MD, MPH, discussed the details of the phase 2 study of adavosertib in recurrent uterine serous carcinoma and the implications of this research for clinical practices.

Osimertinib may not be as effective for the treatment of with non–small cell lung cancer who harbor complex EGFR mutations as it is for those who harbor traditional EGFR mutations, according to a recent study.

The addition of bortezomib consolidation therapy or bortezomib maintenance to the immunochemotherapy regimen rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone improved progression-free survival in patients with mantle cell lymphoma in the post-transplant setting, according to a comparative analysis, CALGB/Alliance 50403 trial.

Chimeric antigen receptor T-cell therapy when administered to patients with non-follicular low-grade lymphoma may experience different efficacy outcomes than patients with aggressive B-cell lymphomas, according to a single-institution retrospective data.

FDA has granted approval to the combination regimen decitabine and cedazuridine as treatment of adult patients with myelodysplastic syndromes under multiple indications.

"The results of the global phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC."

The FDA has lifted a partial clinical hold placed on the phase 2 clinical trial of camidanlumab tesirine in patients with relapsed or refractory Hodgkin lymphoma after ADC Therapeutics submitted further study information to the FDA.

In an interview with Targeted Oncology, Claire Harrison, MD, FRCP, FRCPath, discussed results from the combination of navitoclax and ruxolitinib, as explored in a phase 2 study.