Caroline Seymour

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.

Neoadjuvant treatment with durvalumab plus platinum-based chemotherapy led to a statistically significant improvement in pathologic complete response and major pathologic response compared with chemotherapy alone in patients with resectable non–small cell lung cancer, according to findings from a planned interim analysis of the phase 3 AEGEAN trial.

The addition of durvalumab to gemcitabine and cisplatin demonstrated an improvement in overall survival vs gemcitabine and cisplatin plus placebo as frontline therapy in patients with advanced biliary tract cancer, regardless of primary tumor location.

The novel and highly selective CDK9 inhibitor GFH009 demonstrated encouraging tolerability in patients with advanced, relapsed/refractory acute myeloid leukemia and lymphoma.

The addition of the HER2-Vaxx vaccine to standard-of-care chemotherapy led to a significant improvement in overall survival vs SOC chemotherapy alone in patients with HER2-neu overexpressing advanced and metastatic gastric and gastroesophageal junction cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of olaparib for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk, early breast cancer who have received neoadjuvant or adjuvant chemotherapy.

The FDA has approved lisocabtagene maraleucel as second-line therapy for adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization for asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who were previously treated with at least 2 TKIs.

Treatment with the combination of cobolimab and dostarlimab led to an overall objective response rate and immune-related ORR of 42.9% consisting of all partial responses in patients with advanced or metastatic melanoma.