Managing Editor, OncLive®
Caroline Seymour is your initial point of contact for the OncLive® podcast, OncLive On Air™. She joined the company in 2018 as an assistant editor, with expertise in video production and print/digital publication. Email: [email protected]
The Kidney Cancer Treatment guidelines, housed within the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, have been revised, granting tivozanib Category 1 status as a subsequent therapy for patients with renal cell carcinoma who have received at least 2 prior lines of treatment.
The FDA has granted an orphan drug designation to THIO for the treatment of patients with small cell lung cancer.
Amivantamab in combination with lazertinib plus carboplatin and pemetrexed elicited encouraging responses in pretreated patients with EGFR-mutant non–small cell lung cancer, according to findings from the phase 1 CHRYSALIS-2 trial.
The combination of sotorasib and the small molecule SHP2 inhibitor RMC-4630 led to an investigator-assessed objective response rate of 27% and 50% in pretreated and KRAS G12C inhibitor–naïve patients with non–small cell lung cancer, respectively.
Investigators are evaluating the combination of repotrectinib and osimertinib for the treatment of patients with advanced or metastatic EGFR-mutant non–small cell lung cancer in the phase 1 TOTEM trial.
The novel PSMAxCD38 costimulatory bispecific antibody REGN5678 has shown encouraging efficacy in combination with cemiplimab in patients with advanced metastatic castration-resistant prostate cancer, according to preliminary findings from an ongoing phase 1/2 trial (NCT03972657).
Pembrolizumab plus docetaxel failed to elicit a statistically significant improvement in overall survival and radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer, missing the coprimary end points of the phase 3 KEYNOTE-921 trial.
The FDA has granted a fast track designation to OP-1250 for the treatment of patients with ER-positive, HER2- metastatic breast cancer who have progressed following at least 1 line of endocrine therapy with at least 1 line administered in combination with a CDK4/6 inhibitor.
The phase 3 INTERLINK-1 trial was discontinued after monalizumab plus cetuximab failed to meet a predefined threshold for efficacy compared with cetuximab alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
The FDA has accepted for review a biologics license application for the IL-15 superagonist N-803 for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer carcinoma in situ.
Roy S. Herbst, MD, PhD, discusses the importance of evaluating ways of altering tumor host factors to improve response to immunotherapy in patients with lung cancer.
With two highly selective and active RET inhibitors approved for use in patients with metastatic RET alteration–positive non–small cell lung cancer, the dilemma is not determining which agent to select but ensuring that next-generation sequencing is done up front and in the presence of acquired resistance.
Narjust Florez (Duma), MD, discusses the alarming regularity of disparities in lung cancer care, the elements that perpetuate them, and ways to address them on an individual and institutional level.
The first-in-class p53 reactivator, PC14586, induced a response in approximately 1 of 4 patients with advanced solid tumors harboring p53 Y220C mutations and showcased an acceptable safety profile consisting primarily of grade 1 and 2 events.
IRX-2 failed to demonstrate a statistically significant improvement in event-free survival as neoadjuvant therapy compared with standard of care in patients with newly diagnosed, stage II, III, or IVA squamous cell carcinoma of the oral cavity.
The European Medicines Agency Committee for Medicinal Products for Human Use has recommended that rucaparib no longer be used as monotherapy for the third-line treatment of patients with platinum-sensitive, relapsed or progressive BRCA-mutated high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The FDA has accepted and granted priority review to a supplemental biologics license application for the use of trastuzumab deruxtecan in the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received 1 prior therapy in the metastatic setting.
Zanubrutinib demonstrated a significant improvement in progression-free survival compared with orelabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma or mantle cell lymphoma.
Pembrolizumab plus concurrent chemoradiation followed by pembrolizumab maintenance did not lead to a statistically significant improvement in event-free survival vs concurrent chemoradiation alone in patients with unresected locally advanced head and neck squamous cell carcinoma.
The combination of ofranergene obadenovec and paclitaxel failed to elicit a statistically significant improvement in progression-free survival or overall survival compared with paclitaxel alone in patients with platinum-resistant ovarian cancer, missing the coprimary end points of the OVAL trial.
Neratinib-based combinations, antibody-drug conjugates, and bispecific antibodies represent novel and effective treatment options for patients with pretreated HER2-mutant and HER2-low metastatic breast cancer, but the successful integration of these regimens into care will require further investigation into current definitions of HER2 positivity.
The FDA has removed the clinical hold on the phase 3 FLAMINGO-01 trial allowing the study to continue elevating the activity and safety of the HER2/neu-peptide GLSI-100 in patients with HER2/neu-positive breast cancer who are at high risk for disease recurrence or have residual disease following completion of neoadjuvant and adjuvant trastuzumab-based therapy, according to an announcement from the drug developer.
The FDA has accepted for review a biologics license application for vic-trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer.
Nivolumab alone or in combination with ipilimumab continued to demonstrate sustained clinical benefit as second- and first-line therapy, respectively, in patients with microsatellite instability–high and mismatch repair deficient metastatic colorectal cancer.
The combination of nivolumab and ipilimumab generated a 100% response rate in patients with mismatch repair–deficient colon cancer and a 29% response rate in patients with MMR-proficient disease.
The FDA has granted a fast track designation to belzupacap sarotalocan for the treatment of patients with non–muscle invasive bladder cancer, representing the first virus-like drug conjugate candidate therapy from Aura Biosciences, Inc., the drug developer.
The FDA has accepted for review a biologics license application resubmission for toripalimab both in combination and as monotherapy for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, according to an announcement from drug developer Coherus.
The FDA has accepted a biologics license application and granted a priority review designation to mosunetuzumab, a potential first-in-class CD20 and CD3 T-cell engaging bispecific antibody, for the treatment of patients with relapsed/refractory follicular lymphoma following at least 2 prior systemic therapies.
Drug manufacturer Aileron plans to stop further enrollment into a phase 1b trial (NCT04022876) after the chemoprotective agent ALRN-6924 missed its composite primary end point for patients with advanced p53-mutant non–small cell lung cancer.
The FDA has granted an orphan drug designation to evorpacept, a next-generation CD47 blocker, for use as a potential therapeutic option for patients with acute myeloid leukemia.
