Caroline Seymour

The FDA has granted fast track designation to the first-in-class innate cell engager AFM13 plus AlloNK for the treatment of patients with relapsed/refractory Hodgkin lymphoma.

Zongertinib will proceed to phase 1b evaluation at doses of 120 mg and 240 mg once daily in patients with HER2–mutant non–small cell lung cancer following preliminary efficacy signals and acceptable safety in patients with advanced HER2–mutant solid tumors enrolled in the dose-escalation portion of the phase 1a/b BEAMION Lung-1 trial.

Treatment with at least 90 μg/kg of the novel DLLC-targeting T-cell–engager BI 764532 was well tolerated and led to tumor shrinkage in patients with small cell lung cancer and neuroendocrine carcinoma.

Loncastuximab tesirine-lpyl plus rituximab demonstrated promising antitumor activity and consistent safety signals in patients with relapsed/refractory diffuse large B-cell lymphoma.

No difference in relapse-free survival or non–relapse mortality was seen with intensive vs non-intensive consolidation chemotherapy regimens prior to allogeneic hematopoietic stem cell transplantation in elderly patients over the age of 60 with acute myeloid leukemia in first complete remission.

Amivantamab-vmjw plus carboplatin and pemetrexed, administered with or without lazertinib, significantly improved progression-free survival vs chemotherapy alone in patients with locally advanced or metastatic non–small cell lung cancer with EGFR exon 19 deletions or L858R substitutions after progression on or after osimertinib.

Emerging data continue to shape perioperative therapy decisions for patients with early-stage non–small cell lung cancer.

The FDA has granted 2 breakthrough therapy designations to trastuzumab deruxtecan for the treatment of patients with unresectable or metastatic HER2-positive solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options, and for those with HER2-positive metastatic colorectal cancer who have received at least 2 prior lines of therapy.

The FDA and Eagle Pharmaceuticals have agreed on the next steps for the development of EA-114, an estrogen receptor antagonist and novel formulation of fulvestrant used in the treatment of postmenopausal women with breast cancer.

The European Commission has approved pembrolizumab for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 1.

The addition of tumor treating fields to paclitaxel did not result in a statistically significant improvement in overall survival vs paclitaxel alone in patients with platinum-resistant ovarian cancer, failing to meet the primary end point of the phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 trial.

The combination of pembrolizumab and lenvatinib demonstrated a statistically significant improvement in progression-free survival and objective response rate but failed to improve overall survival compared with pembrolizumab plus placebo as frontline therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.

Interim data from the phase 3 CABINET trial demonstrated significant improvement in progression-free survival with cabozantinib vs placebo in patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors following progression on prior systemic therapy.

The Japanese Ministry of Health, Labour, and Welfare has approved the combination of olaparib plus abiraterone acetate and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated castration-resistant prostate cancer with distant metastasis.

The addition of the investigational anti-TIGIT immunotherapy tiragolumab to atezolizumab demonstrated a numerical but not statistically significant improvement in overall survival vs atezolizumab alone as frontline therapy for patients with PD-L1–high, locally advanced or metastatic non–small cell lung cancer.

Second-line treatment with GNOS-PV02 plus plasmid-encoded interleukin-12 followed by electroporation elicited complete molecular response detected via circulating tumor DNA in 4 additional patients with advanced hepatocellular carcinoma enrolled in the phase 1b/2a GT-30 study.

The FDA has placed another partial clinical hold on the enrollment of new patients in United States clinical trials evaluating the potential first-in-class investigational anti-CD47 immunotherapy magrolimab for the treatment of acute myeloid leukemia.

The combination of cabozantinib and atezolizumab led to a statistically significant improvement in progression-free survival compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer and measurable soft tissue disease following 1 prior novel hormonal therapy, meeting one of the primary end points in the primary analysis of the phase 3 CONTACT-02 trial.

TNB-486 demonstrated sustained antitumor activity in all but 1 patient with relapsed/refractory follicular lymphoma, regardless of CD20 status, as well as number and type of prior therapy.

Treatment with belzutifan demonstrated a statistically significant and clinically meaningful improvement in progression-free survivalcompared with everolimus in patients with advanced renal cell carcinoma that has progressed on prior PD-1/PD-L1 and VEGF inhibitors, in sequence or in combination.

The addition of quizartinib to standard induction and consolidation chemotherapy with idarubicin plus cytarabine followed by maintenance therapy led to an improvement in event-free survival compared with placebo plus chemotherapy in patients with FLT3-ITD wild-type acute myeloid leukemia.

The FDA has granted an orphan drug designation to NXP800 for the treatment of patients with cholangiocarcinoma.

MB-106, a first-in-class, CD20-targeted autologous CAR T-cell therapy, led to durable clinical responses with low-grade cytokine release syndrome in patients with indolent lymphoma.

Use of Copper 64 PSMA I&T for PET/CT imaging met the threshold for significance regarding region-level correct localization rate and patient-level correct detection rate in patients with histologically confirmed metastatic prostate cancer, meeting the coprimary end points of the phase 2 SOLAR trial.

The FDA has granted an orphan drug designation to quratusugene ozeplasmid (Reqorsa) for the treatment of patients with small cell lung cancer.

The addition of the chimeric monoclonal antibody CAEL-101 to standard therapy with cyclophosphamide, bortezomib, and dexamethasone with or without daratumumab demonstrated a manageable toxicity profile with prolonged clinical benefit in patients with amyloid light-chain amyloidosis.

The FDA has approved niraparib plus abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive, metastatic castration-resistant prostate cancer, as detected by an FDA-approved test.

The FDA has approved a study may proceed letter in advance of its 30-day review period to Oncternal Therapeutics for its phase 1/2 study evaluating ONCT-534, a novel dual-action AR inhibitor in patients with mCRPC who have relapsed or are refractory to approved AR signaling inhibitors.

The safety and efficacy of zipalertinib plus platinum-based chemotherapy will be compared with platinum-based chemotherapy alone in patients with treatment-naïve, locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations in the phase 3 REZILIENT3 trial.

The FDA has released a complete response letter to its biologics license application resubmission, indicating that it needs more data to support approval for remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft-vs-host disease.