All Oncology News

The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.

FDA Allows Continuation of Phase 1/2 Trial of ONCT-534 in mCRPC

August 11th 2023

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.

BDC-1001 Monotherapy Under Further Evaluation in Phase 2 Trial in HER2+ Cancers

August 11th 2023

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.

ORCHID Trial of Olaparib Monotherapy Could Lay Groundwork for Investigating PARP Inhibitors in Advanced RCC

August 11th 2023

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.

Evaluation of Novel Agents and Combinations Aims to Improve Outcomes in Frontline RCC

August 10th 2023

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.

SAMETA Trial Evaluates Efficacy of Savolitinib Plus Durvalumab in MET-Driven Papillary RCC

August 10th 2023

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.

Linvoseltamab Produces Durable Responses in Relapsed/Refractory Multiple Myeloma

August 10th 2023

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.

Huntsman Cancer Institute Research Highlights For July 2023

August 10th 2023

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

Glecirasib Receives Breakthrough Therapy Designation in China for KRAS G12C–Mutated Pancreatic Cancer

August 10th 2023

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.

Lasofoxifene/Abemaciclib Combination Aims to Fill Need in ESR1-Mutant, ER+/HER2- Breast Cancer

August 10th 2023

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.

LITESPARK-024 Trial to Examine HIF-2α and CDK4/6 Inhibition With Belzutifan Plus Palbociclib in Advanced RCC

August 10th 2023

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.

Lack of Clinical Benefit Leads to End of Development for Etrumadenant in mCRPC

August 10th 2023

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.

FDA Approves Talquetamab for Relapsed/Refractory Multiple Myeloma

August 10th 2023

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.

FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in Head and Neck Cancer

August 9th 2023

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.

Dostarlimab/Chemo Approval Changes Treatment Paradigm for dMMR/MSI-H Advanced or Recurrent Endometrial Cancer

August 9th 2023

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.

Real-World Data Support Role of Palbociclib in HR+/HER2– Metastatic Breast Cancer

August 9th 2023

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.

FDA Grants Regular Approval to Pralsetinib for Metastatic RET Fusion+ NSCLC

August 9th 2023

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.

Novel PROTACs Broaden the HR+ Breast Cancer Investigational Landscape

August 9th 2023

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.

City of Hope Ranks Among Nation’s Top 10 Best Hospitals for Cancer

August 9th 2023

The ranking by U.S. News & World Report marks the latest recognition for the organization as one of the nation’s elite cancer hospitals.

MDNA11 Generates Activity, Safety in Advanced Solid Tumors

August 9th 2023

Treatment with the long-acting interleukin-2 superkine led to durable tumor control and no dose-limiting toxicities in patients with advanced solid tumors, according to data from the dose-escalation portion of the phase 1/2 ABILITY-1 trial.

Kirtane Highlights Uniqueness of Solid Tumor CAR T-Cell Agent A2B530

August 9th 2023

Kedar Kirtane, MD, speaks on the unique mechanism of action of A2B530 and how the agent could represent a huge leap forward in the application of CAR T-cell agents for patients with solid tumors if the EVEREST-1 study proves to be positive.