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.

Tamibarotene, Azacitidine, and Venetoclax May Strengthen AML Armamentarium

April 27th 2023

Brian Ball, MD, discusses the significance of targeting RARA in AML, the rationale for SELECT-AML-1, and additional AML research that may contribute to the broadening treatment paradigm in the future.

Taylor Highlights Safety and Efficacy of IgG4 Monoclonal Antibody IO-108 in Advanced Solid Tumors

April 26th 2023

Matthew H. Taylor, MD, discusses findings from a phase 1 study of IO-108 in advanced solid tumors, which was presented during the 2023 AACR Annual Meeting.

Glofitamab Approaches EU Approval for R/R Diffuse Large B-cell Lymphoma

April 26th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of glofitamab for fixed-duration use in adult patients with relapsed or refractory diffuse large B-cell lymphoma following 2 or more lines of systemic therapy.

VT3989 Shows Activity, Tolerability in Mesothelioma and Other NF2-Mutated Solid Tumors

April 26th 2023

VT3989, a first-in-class YAP/TEAD inhibitor, showcased durable antitumor activity and tolerability in patients with malignant mesothelioma and other solid tumors harboring NF2 mutations, according to data from a phase 1 trial presented at the 2023 AACR Annual Meeting.

Addressing the Challenge: Connecting Black Women with Clinical Trials

April 26th 2023

Clinical trials have strikingly low rates of Black participants, even those centered on diseases that disproportionately affect Black women in particular, such as breast cancer, the most commonly diagnosed cancer and the leading cause of cancer death for this population.

ASTRO/ESTRO Release Clinical Guideline for Local Therapy in Oligometastatic NSCLC

April 26th 2023

The American Society for Radiation Oncology and European Society for Radiotherapy & Oncology have released the first clinical guideline on the use of definitive local therapy, including radiation and surgery, for the treatment of patients with oligometastatic non–small cell lung cancer.

Furmonertinib Plus Icotinib Elicits Antitumor Activity in EGFR+ NSCLC With CNS Metastases

April 26th 2023

First-line treatment with furmonertinib plus icotinib induced responses in patients with EGFR-mutant non–small cell lung cancer. including those with central nervous system metastases, according to data from an ongoing phase 2 trial.

Iptacopan Meets Primary End Point of APPOINT-PNH Trial in Paroxysmal Nocturnal Hemoglobinuria

April 26th 2023

Iptacopan elicited improved hemoglobin levels measuring at least 2 g/dL higher vs baseline, leading to transfusion independence after 24 weeks in approximately 92.2% of patients with complement inhibitor–naïve paroxysmal nocturnal hemoglobinuria.

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.