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 Grants Orphan Drug Designation to Paxalisib for Atypical Rhabdoid, Teratoid Tumors
June 20th 2022The FDA has granted an orphan drug designation to paxalisib for use as a potential therapeutic option for patients with atypical rhabdoid and teratoid tumors, a rare and highly aggressive pediatric brain cancer.
Cilta-cel Produces Durable Responses in Relapsed/Refractory Multiple Myeloma
June 20th 2022A single infusion of the CAR T-cell therapy ciltacabtagene autoleucel produced deep and durable responses in patients with relapsed/refractory multiple myeloma with a manageable toxicity profile, according to long-term follow-up data of the phase 1b/2 CARTITUDE-1 trial.
Trastuzumab Deruxtecan Elicits Statistically Significant PFS in HR-Positive/HER2-Low Breast Cancer
June 20th 2022Fam-trastuzumab deruxtecan-nxki demonstrated a statistically significant benefit in progression-free survival in patients with HER2-low metastatic breast cancer, meeting the primary end point of the phase 3 DESTINY-Breast04 trial and changing the standard of care for this patient population.
European Medicines Agency Validates Type II Variation Application for Liso-cel in Second-line LBCL
June 20th 2022The European Medicines Agency has verified its type II variation application to extend the indication for lisocabtagene maraleucel to include the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma, who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant.
A Molecular Revolution Is Underway in Thoracic Oncology
June 20th 2022Targetable alterations including BRAF V600E, EGFR exon 20 insertions, KRAS G12C mutations, MET exon 14 alterations, NTRK and RET rearrangements have taken up recent focus for investigators as data are pushing novel agents through the regulatory processes.
T-VEC Plus Pembrolizumab Generates Promising Responses, Safety in PD-1–Refractory Advanced Melanoma
June 20th 2022Adding talimogene laherparepvec to pembrolizumab led to encouraging responses with a manageable safety profile in patients with advanced melanoma who progressed on prior anti–PD-1 therapy, most notably in the adjuvant setting, according to findings from the phase 2 MASTERKEY-115 trial.
Repotrectinib Receives Breakthrough Therapy Designations in China for ROS1+ NSCLC
June 17th 2022The China National Medical Products Administration’s Center for Drug Evaluation granted 2 breakthrough therapy designations to repotrectinib for the treatment of patients with ROS1-positive metastatic non–small cell lung cancer.
Fedratinib with GI Prophylaxis Has Tolerable Safety Profile in Myelofibrosis After Prior Ruxolitinib
June 17th 2022Fedratinib was shown to be generally well tolerated in older patients with myelofibrosis who had received at least 3 months of prior ruxolitinib, according to findings from the phase 3b FREEDOM trial.
Individualized Care Informs Treatment Modality Choices in Pelvic and Sacral Ewing Carcinoma
June 17th 2022R. Lor Randall, MD, FACS, discusses the similar benefits offered by radiation and surgery, improved surgical techniques, concerns with morbidity with each approach, and the next steps surgeons and radiation therapists can take to increase patient survival in nonmetastatic pelvic and sacral Ewing carcinoma.
Adjuvant and Neoadjuvant Treatments Chart New Course in Advanced RCC
June 17th 2022A panel of kidney cancer experts discuss how therapeutic strategies in the neoadjuvant and adjuvant settings are affecting outcomes and how treatment selection in the first line has shifted approaches in the second and later lines of therapy.
Hormone Therapies, ADCs Elicit Long-Term Survival Benefits Across Breast Cancer Subtypes
June 17th 2022Novel combinations with CDK4/6 inhibitors, antibody-drug conjugates, and oral selective estrogen receptor degraders are rapidly changing the treatment paradigm in hormone receptor–positive and HER2-positive breast cancer.
Onilcamotide Fails to Reduce Risk of Progression in Prostate Cancer With Biochemical Recurrence
June 16th 2022The peptide cancer vaccine onilcamotide failed to show superiority over placebo in terms of preventing progression in patients with prostate cancer and biochemical recurrence following curative-intent therapy, missing the primary end point of the phase 2b BRaVac trial.
Colon Microbes Provide Clues to Favorable Treatment Options in a Subset of Colon Cancer Patients
June 16th 2022Investigators from Rutgers Cancer Institute of New Jersey, New Jersey’s only National Cancer Institute-Designated Comprehensive Cancer Center, led a collaborative study to examine the patterns of druggable oncogenic fusions in colon cancer specimens including microsatellite-stable and unstable tumors.
Cosibelimab Continues to Show Promise in Locally Advanced Cutaneous Squamous Cell Carcinoma
June 16th 2022The PD-L1 antibody cosibelimab was found to elicit an encouraging objective response rate in patients with locally advanced cutaneous squamous cell carcinoma who were not eligible to undergo curative surgery or radiation.
Efforts Are Needed to Address the Enigmatic Rise of Young-Onset Gastrointestinal Cancers
June 16th 2022Despite a steady decline in incidence and mortality rates of many cancers among older individuals in the United States and other high-income countries, an alarming rise in young-onset gastrointestinal cancers has simultaneously occurred.
Quavonlimab/Pembrolizumab Combo Shows Modest Antitumor Activity in Advanced Melanoma
June 16th 2022The combination of quavonlimab and pembrolizumab was found to be generally well tolerated and to have modest antitumor activity in patients with advanced melanoma that progressed on a PD-1/PD-L1 inhibitor, according to data from a phase 1/2 trial (NCT03179436).
Duvelisib and Oral Azacitidine Under Study With CHO(E)P in Peripheral T-Cell Lymphoma
June 15th 2022Duvelisib and oral azacitidine are each being studied in combination with CHOP/CHOEP chemotherapy in patients with previously untreated CD30-negative peripheral T-cell lymphoma in the randomized phase 2 Alliance A059102 trial.