All Oncology News

The FDA has granted an orphan drug designation to quratusugene ozeplasmid (Reqorsa) for the treatment of patients with small cell lung cancer.

Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.

Several articles featured in a recent issue of the highly respected publication the Medical Letter on Drugs and Therapeutics highlight themes across drug development that are relevant within the broad antineoplastic arena. The topics range from appropriate control arms in randomized clinical trials to sponsorship of trials to the rationale for developing novel agents when suitable, cost-effective biosimilar and generic products are available.

Treatment with the GVAX pancreatic cancer vaccine plus nivolumab and urelumab increased the presence of intratumoral activated cytotoxic T cells and showed early signs of efficacy in patients with resectable pancreatic adenocarcinoma.

Single-agent IBI322 elicited responses with favorable safety in patients with classical Hodgkin lymphoma that had become resistant to anti–PD-1/PD-L1 therapy, according to data from a phase 1 trial.

The addition of the chimeric monoclonal antibody CAEL-101 to standard therapy with cyclophosphamide, bortezomib, and dexamethasone with or without daratumumab demonstrated a manageable toxicity profile with prolonged clinical benefit in patients with amyloid light-chain amyloidosis.

The FDA has approved niraparib plus abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive, metastatic castration-resistant prostate cancer, as detected by an FDA-approved test.

The novel personalized cancer vaccine IFx-Hu2.0 was found to be safe and well tolerated with weekly dosing in patients with checkpoint inhibitor–resistant cutaneous squamous cell carcinoma and Merkel cell carcinoma, according to data from an ongoing phase 1b trial.

The combination of teclistamab and nirogacestat produced high and deep responses in patients with relapsed/refractory multiple myeloma.

Helena A. Yu, MD, discusses the investigation of BL-B01D1 in patients with advanced solid tumors, the potential significance of this research for those with EGFR-mutant and wild-type disease, and the expanding body of evidence supporting continued antibody-drug conjugate development in non–small cell lung cancer.

Treatment with the second-generation BTK inhibitor tirabrutinib continued to elicit durable responses in patients with relapsed/refractory primary central nervous system lymphoma, according to findings from the final 3-year analysis of a phase 1/2 trial.

The addition of ofranergene obadenovec to paclitaxel failed to significantly improve survival outcomes compared with paclitaxel alone in patients with platinum-resistant ovarian cancer.

Florida Cancer Specialists & Research Institute, LLC, physicians and senior leaders are co-authors of a study that confirms the effectiveness of trilaciclib for the treatment of adult patients with extensive-stage small cell lung cancer.

The FDA has approved a study may proceed letter in advance of its 30-day review period to Oncternal Therapeutics for its phase 1/2 study evaluating ONCT-534, a novel dual-action AR inhibitor in patients with mCRPC who have relapsed or are refractory to approved AR signaling inhibitors.

The first patients have been dosed in the phase 2 portion of a phase 1/2 trial evaluating BDC-1001 monotherapy in patients with HER2-positive colorectal cancer, endometrial cancer, and gastroesophageal cancer.

Yasser Mohamed Ali Ged, MBBS, highlights the early efficacy seen in patients with renal cell carcinoma with BAP1 mutations and next steps for the ORCHID trial.

Ulka Nitin Vaishampayan, MBBS, discusses factors to consider for choosing between immuno-oncology/immuno-oncology and VEGF TKI/immuno-oncology combinations for the frontline treatment of patients with renal cell carcinoma, areas of ongoing research in this disease, and treatment updates across the prostate cancer spectrum.

The safety and efficacy achieved with the combination of savolitinib and durvalumab vs standard-of-care sunitinib or durvalumab monotherapy will be evaluated in patients with MET-driven papillary renal cell carcinoma in the phase 3 SAMETA trial.

Hans Lee, MD, discusses unmet needs in patients with relapsed/refractory multiple myeloma, highlights key efficacy and safety findings from the LINKER-MM1 trial, and how these data may inform the future of the multiple myeloma treatment paradigm.

This month, researchers reduce the risk of infections after pancreatic surgery and discover the best cost-effective treatment combination for prostate cancer patients.

China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.

Finding effective treatments beyond the first line for patients with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer and an ESR1 mutation remains a challenge following development of resistance to agents.

David F. McDermott, MD, discusses how combining HIF-2α inhibition with CDK4/6 inhibition could be an effective treatment regimen in patients with renal cell carcinoma and shared details from the LITESPARK-024 trial.

The development of etrumadenant as a potential treatment option for patients with metastatic castration-resistant prostate cancer will be discontinued after data from the phase 1/2 ARC-6 trial did not demonstrate a sufficient clinical benefit for etrumadenant plus zimberelimab and docetaxel compared with docetaxel alone.

The FDA has granted accelerated approval to talquetamab-tgvs for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

The FDA has issued a complete response letter to the new drug application seeking the approval of avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.

Dana Chase, MD, FACOG, discusses key efficacy, safety, and quality of life data from the RUBY trial supporting the FDA approval of dostarlimab and explains how this approval could help improve the efficacy of current chemotherapy regimens in advanced-stage or recurrent endometrial cancer.

Bhuvaneswari Ramaswamy, MD, and colleagues highlight treatment for patients with HR-positive breast cancer, discuss the role of pembrolizumab plus chemotherapy in early-stage triple-negative breast cancer, and expand on unmet needs for patients with metastatic HER2-positive breast cancer.

The FDA has granted regular approval to pralsetinib (Gavreto) for adult patients with metastatic RET fusion–positive non–small cell lung cancer, as detected by an FDA-approved test.

Seth Wander, MD, PhD, discusses evidence to support the investigation of PROTACs in patients with hormone receptor–positive breast cancer; preliminary efficacy and safety findings with vepdegestrant; and potential strategies for targeting acquired ESR1 resistance mutations.