Chris Ryan

The combination of tucatinib and trastuzumab produced promising response rates in patients with previously treated HER2-positive metastatic colorectal cancer.

The FDA has placed a partial clinical hold on a phase 1 trial investigating FHD-286 as a treatment for patients with relapsed and/or refractory acute myeloid leukemia and myelodysplastic syndrome.

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of adagrasib for therapeutic use in previously treated patients with non–small cell lung cancer harboring a KRAS G12C mutation.

The FDA has granted an orphan drug designation to XMT-2056 for use as a potential therapeutic option for patients with gastric cancer.

Dabrafenib plus trametinib produced clinically meaningful objective responses rates in patients with recurrent or progressive BRAF V600E mutation–positive glioma.

Investigators have initiated a phase 1 trial exploring ACLX-001, a novel CAR T-cell therapy using the ARC-SparX platform, in patients with relapsed/refractory multiple myeloma.

The combination of intratumoral vidutolimod and intravenous pembrolizumab demonstrated promising clinical activity in patients with PD-1 refractory melanoma.

PET/CT scans conducted with 18F-rhPSMA-7.3 frequently resulted in post-scan disease upstaging compared with baseline conventional imaging in patients with prostate cancer recurrence.

The addition of navicixizumab to paclitaxel produced encouraging responses with manageable toxicity in patients with platinum-resistant ovarian cancer irrespective of prior treatment with bevacizumab.

The first-in-class, off-the-shelf therapeutic cancer vaccine VB10.16 in combination with atezolizumab generated positive responses in heavily pretreated patients with HPV16-positive advanced cervical cancer.

The addition of abemaciclib to endocrine therapy improved invasive disease-free survival and distant relapse-free survival vs endocrine therapy alone in patients with high-risk, hormone receptor–positive, HER2-negative, early-stage breast cancer, irrespective of menopausal status.

The addition of nivolumab to trastuzumab deruxtecan did not result in a marked clinical benefit in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

Neoadjuvant therapy generated similar benefits to adjuvant therapy in patients with early-stage, HER2-positive breast cancer treated in China, suggesting that neoadjuvant therapy should be used in this patient population.

The addition of ribociclib to fulvestrant continued to significantly prolong overall survival, delayed time to second disease progression, and improved chemotherapy-free survival vs placebo plus fulvestrant in the first-line treatment of patients with advanced hormone receptor–positive, HER2-negative breast cancer.

The safety and efficacy of the combination of the oncolytic immunotherapy CG0070 and nivolumab is under exploration as a potential therapeutic option in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy, as part of the phase 1b CORE-002 trial.

Pembrolizumab with or without chemotherapy resulted in a numerically longer overall survival benefit vs cetuximab plus chemotherapy in patients with head and neck squamous cell carcinoma and a PD-L1 combined positive score (CPS) between 1 and 19, but did not improve survival in the subset with a PD-L1 CPS of less than 1.

Heather McArthur, MD, MPH, discusses key treatment developments in early-stage and metastatic HER2-positive breast cancer and triple-negative breast cancer, plus ongoing research at UT Southwestern Harold C. Simmons Comprehensive Cancer Center.

Christos Vaklavas, MD, discusses the increasing emphasis on investigating tumor biology in breast cancer, plus the evolving treatment landscapes in HER2-positive breast cancer, hormone receptor–positive, HER2-negative breast cancer, and triple-negative breast cancer.

The European Commission has granted an approval to the combination of pembrolizumab and chemotherapy, with or without bevacizumab, for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer whose tumors have a PD-L1 combined positive score of 1 or higher.

The administration of a third dose of a SARS-CoV-2 mRNA vaccine yielded seroconversion responses in patients treated with hematopoietic cell transplantation or cellular therapy following initial failure of seroconversion after the first 2 vaccine doses.

The FDA has accepted for filing the new drug application resubmission for a unique formulation of sodium thiosulfate for the prevention of platinum-induced ototoxicity in patients between the ages of 1 month and 18 years who have localized, nonmetastatic, solid tumors.

The combination of tislelizumab and chemotherapy resulted in a significant improvement in overall survival compared with chemotherapy alone in patients with locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, irrespective of PD-L1 expression.

The FDA has granted a fast track designation to VB-111, a targeted anticancer viral gene therapy, for use as a potential therapeutic option in patients with platinum-resistant ovarian cancer.

Jun Zhang, MD, PhD, discusses key clinical trials utilizing immunotherapy in non–small cell lung cancer, the continued importance of biomarker testing to help inform treatment decisions, and targeted therapies for EGFR, MET, and ALK mutations.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab alone after surgery for adult patients with locally advanced or early-stage triple-negative breast cancer who are at a high risk for recurrence.

The CAR T-cell therapies axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel evoked responses without increased risk of cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome in patients with primary or secondary central nervous system large B-cell lymphoma.

The FDA has granted an orphan drug designation to the PD-1 inhibitor toripalimab as a potential therapeutic option for patients with small cell lung cancer.

The FDA has granted a fast track designation to the antibody-drug conjugate CMG901 as a single-agent treatment for patients with unresectable or metastatic gastric and gastroesophageal junction cancer that is relapsed or refractory to approved therapies.

Roy S. Herbst, MD, PhD, discusses the rationale for exploring immunotherapy/TKI combinations like pembrolizumab plus lenvatinib in patients with non–small cell lung cancer, and outlined the different efforts that comprise the LEAP clinical trial program.

The safety, tolerability, and preliminary efficacy of the anti-HER2 CAR macrophage therapy, CT-0508, will be investigated in patients with solid tumors and HER2 overexpression, as part of a first-in-human phase 1 study.