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.

Petosemtamab Generates Early Clinical Activity and Tolerability in HNSCC

April 26th 2023

The bispecific antibody petosemtamab delivered responses with a manageable safety profile in patients with advanced head and neck squamous cell carcinoma.

FIDES-02 Data Fail to Support the Development of Derazantinib in Metastatic Urothelial Cancer

April 25th 2023

Andrea Necchi, MD, discusses the efficacy and safety data reported from the FIDES-02 study, explains the clinical relevance of these data despite the trial’s negative result, and highlights several other influential studies presented at the 2023 Genitourinary Cancers Symposium.

AZD3759 Elicits Responses in Untreated EGFR-Mutant NSCLC With CNS Metastases

April 25th 2023

AZD3759 elicited clinical responses and had an acceptable toxicity profile when administered at a dose of 200 mg twice daily in patients with untreated EGFR-mutant non–small cell lung cancer and central nervous system metastases, according to data from the phase 2 TRUMP trial.

TRAVERSE Study Shows Preliminary Efficacy and Safety of ALLO-316 in Advanced Clear Cell RCC

April 25th 2023

Samer A. Srour, MB ChB, MS, explains the unique construction of ALLO-316, the potential for ALLO-316 to address an unmet need in patients with clear cell renal cell carcinoma, and how early data from the TRAVERSE study support the continued investigation of ALLO-316 in patients with CD70-expressing tumors.

Fox Chase Cancer Center’s Edna ‘Eti’ Cukierman Appointed Chair-Elect of the American Association for Cancer Research’s Tumor Microenvironment Working Group

April 25th 2023

Edna “Eti” Cukierman, PhD, was been appointed chair-elect of the AACR Tumor Microenvironment Working Group at the AACR Annual Meeting 2023.

FDA Grants Fast Track Designation to 177Lu-PNT2002 for mCRPC

April 25th 2023

The FDA has granted a fast track designation to 177Lu-PNT2002 for the treatment of patients with metastatic castration-resistant prostate cancer.

EMA Validates Type II Variation Application for Dostarlimab/Chemo for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

April 25th 2023

The European Medicines Agency has validated a type II variation for potential approval of dostarlimab in combination with carboplatin and paclitaxel for the treatment of patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

Restricted Indication for Maintenance Niraparib Therapy in Recurrent Ovarian Cancer Further Supported by Final Survival Analysis of NOVA Trial

April 25th 2023

Ursula A. Matulonis highlights previous data from the phase 3 ENGOT-OV16/NOVA trial initial readout and subsequent preplanned overall survival analysis, discusses new findings from the final analysis, and emphasizes how these data clarify some of the study’s limitations and reinforce the importance of adhering to the adjusted FDA label for niraparib in recurrent ovarian cancer.

Durvalumab Plus Chemo Is Tolerable in Real-World Representative ES-SCLC Population

April 25th 2023

First-line durvalumab plus up to 6 cycles of platinum and etoposide is safe and tolerable with signals of clinical efficacy consistent with those previously seen in patients with treatment-naïve extensive-stage small cell lung cancer.

FDA Places Partial Clinical Hold on Trial of FHD-609 in Synovial Sarcoma and SMARCB1-Deleted Tumors

April 24th 2023

The FDA has placed a partial clinical hold on the phase 1 trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of FHD-609 in patients with advanced synovial sarcoma and SMARCB1-deleted tumors.

Darovasertib Plus Crizotinib Shows Early Promise in Metastatic Uveal Melanoma

April 24th 2023

The combination of darovasertib and crizotinib demonstrated clinical activity and an acceptable safety profile when utilized in first- and any-line patients with metastatic uveal melanoma.

Niraparib/Abiraterone Acetate Combo Approved in Europe for BRCA1/2+ mCRPC

April 24th 2023

The European Commission has granted marketing authorization to the dual action tablet comprised of niraparib and abiraterone acetate to be administered with prednisone or prednisolone in adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

Subgroup Analysis Shows Consistent Benefit for Dostarlimab Plus Chemo in Nonsquamous NSCLC

April 24th 2023

Overall response rates were similar across subgroups of patients with nonsquamous non–small cell lung cancer for the combinations of dostarlimab-gxly plus chemotherapy and pembrolizumab plus chemotherapy, and responses numerically favored the dostarlimab-based combination in most subgroups, according to a subgroup analysis of the phase 2 PERLA trial.

Study: Vitamin D May Play a Role in Prostate Cancer Disparities

April 24th 2023

Vitamin D deficiency could be the reason African American men experience more aggressive prostate cancer at a younger age compared with European American men.

Sugemalimab Monotherapy Has Clinical Benefit in NK/T-Cell Lymphoma

April 24th 2023

The PD-L1 inhibitor sugemalimab produced durable responses with a tolerable safety profile in patients with relapsed/refractory natural killer/T-cell lymphoma, according to findings from a preplanned primary analysis of the multicenter, single-arm, phase 2 GEMSTONE-201 trial.

Ribociclib Plus Letrozole Has Activity in Recurrent Low-Grade Serous Ovarian Cancer

April 24th 2023

Brian M. Slomovitz, MD, discusses key efficacy and safety data seen with ribociclib and letrozole in the GOG 3026 trial and planned efforts to identify associated biomarkers and pursue FDA approval for the combination in advanced, recurrent low-grade serous ovarian cancer.

PARP Inhibitors, ADCs, and Immunotherapy Approaches Advance the Treatment Paradigm in Gynecologic Oncology

April 24th 2023

Joshua G. Cohen, MD, FACOG, FACS, expands on the role of PARP inhibitors in the recurrent and up-front settings in ovarian cancer, and the clinical significance of the RUBY and NY-GY018 trials in endometrial cancer.

LY3537982 Demonstrates Tolerability and Preliminary Efficacy in KRAS G12C–mutated Advanced Solid Tumors

April 23rd 2023

Joshua K. Sabari, MD, shares how the unique pharmacokinetics and mechanism of action for LY3537982 supported its investigation in the LOXO-RAS- 20001 study, findings presented at AACR, and how this research could address unmet needs in patients with KRAS G12C–mutant solid tumors.

Long-term Outcomes From JAVELIN Bladder 100 Solidify Maintenance Avelumab as SOC in Metastatic Urothelial Carcinoma

April 22nd 2023

A long-term post-hoc analysis from the JAVELIN Bladder 100 trial demonstrated that first-line maintenance avelumab elicited similar overall survival and progression-free survival benefits vs best supportive care alone in patients with advanced urothelial carcinoma.

Tucatinib/Trastuzumab Approval Highlights Expansion of Tailored Therapies in HER2+ CRC

April 21st 2023

John L. Hays, MD, PhD, discusses the importance of tailoring therapies for patients with CRC who express HER2 or have other actionable targets, the need to develop optimal sequences for local and systemic therapy in CRC, and key updates in hepatocellular carcinoma and pancreatic cancer.