Kristi Rosa

The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.

An independent data monitoring committee has recommended that the phase 3 INNOVATE-3 trial exploring the safety and efficacy of tumor treating fields in combination with paclitaxel in patients with platinum-resistant ovarian cancer proceed to the final analysis.

The FDA has approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have previously received other anticancer therapies.

Temozolomide priming followed by the combination of low-dose ipilimumab and nivolumab may produce durable clinical benefit in microsatellite stable and MGMT-silenced metastatic colorectal cancer.

The combination of abemaciclib and letrozole produced encouraging responses with an acceptable toxicity profile in patients with estrogen receptor–positive, recurrent or metastatic endometrial cancer with endometrioid histology, according to data from a phase 2 trial.

The FDA has approved pembrolizumab for use as a single agent in the treatment of patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair deficient, and who experienced disease progression following previous systemic therapy in any setting and are not candidates for curative surgery or radiation.

Mirvetuximab soravtansine was found to produce clinically meaningful antitumor activity with acceptable safety and tolerability in patients with platinum-resistant ovarian cancer and high folate receptor–alpha (FRα) expression.

The FDA has approved the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma.

Pembrolizumab was found to significantly improve disease-free survival vs placebo when used in the adjuvant treatment of patients with stage IB to IIIA non–small cell lung cancer following surgical resection, meeting 1 of the dual primary end points of the phase 3 KEYNOTE-091 trial.

Selinexor reduced the risk of disease progression or death by 30% in an audited intent-to-treat population of patients with advanced or recurrent endometrial cancer who received frontline chemotherapy, and by 62% in a subset of patients with p53 wild-type disease, according to data from the phase 3 SIENDO trial.

The FDA has granted an orphan drug designation to the investigative allogeneic unmodified gamma delta T-cell product, TCB-002, for use as a potential therapeutic option in patients with relapsed/refractory acute myeloid leukemia.

The FDA has granted a fast track designation to the novel immunostimulant 7HP349 for use in combination with a CTLA-4 inhibitor in patients with unresectable or metastatic malignant melanoma in whom a PD-L1 inhibitor has failed.

The FDA has approved the FoundationOne CDx for use as a companion diagnostic to determine which patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 substitutions may derive benefit from EGFR TKIs that have been greenlit by the agency for this indication.

At a median follow-up of 3.5 years, adjuvant olaparib significantly improved overall survival vs placebo in patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who received prior chemotherapy before or after surgery.

The Ministry of Health, Labour, and Welfare has approved Guardant360 CDx to perform comprehensive genomic profiling in patients with advanced solid cancers.

The fixed-dose combination of relatlimab and nivolumab continued to demonstrate a consistent progression-free survival benefit, showcased a clinically meaningful improvement in overall survival, and elicited a higher objective response rate than nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

Allarity Therapeutics, Inc. has filed a formal request with the FDA to hold a Type C meeting where they can discuss possible clinical paths to support the approval of dovitinib in renal cell carcinoma, as well as its DRP-Dovitinib companion diagnostic.

The phase 3 KEYLYNK-001 trial evaluating the combination of pembrolizumab and olaparib in patients with metastatic castration-resistant prostate cancer who progressed following chemotherapy and either abiraterone acetate or enzalutamide will be discontinued for futility.

The combination of cabozantinib and atezolizumab was not found to result in an improvement nor a detriment in overall survival vs sorafenib when used in previously untreated patients with advanced hepatocellular carcinoma, according to data from the phase 3 COSMIC-312 trial.

Amcenestrant did not improve progression-free survival per independent central review vs physician’s choice of endocrine treatment in select patients with locally advanced or metastatic, estrogen receptor–positive, HER2-negative breast cancer, missing the primary end point of the phase 2 AMEERA-3 trial.

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.

The FDA has approved the BRACAnalysis CDx assay for use as a companion diagnostic to select patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who may derive clinical benefit from treatment with olaparib.

A marketing authorization application has been submitted to the European Medicines Agency for 2 indications of ivosidenib: in combination with azacitidine in the frontline treatment of patients with IDH1-mutated acute myeloid leukemia who are not candidates for intensive chemotherapy and in previously treated patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma.

The combination of ribociclib and letrozole resulted in a statistically significant improvement in overall survival vs letrozole alone in patients with postmenopausal, hormone receptor–positive, HER2-negative advanced breast cancer, with this benefit continuing to increase over time, supporting the use of this combination as a frontline treatment in this population.

A supplemental new drug application and a Variation Type II application have been submitted to the FDA and the European Medicines Agency, respectively, seeking the approval of darolutamide plus docetaxel in patients with metastatic hormone-sensitive prostate cancer.

The FDA has granted an orphan drug designation to epcoritamab for use as a potential therapeutic option for patients with follicular lymphoma.

Although the addition of copanlisib to ibrutinib resulted in a high overall response rate in patients with relapsed/refractory mantle cell lymphoma, the regimen was found to have additive toxicity, according to findings from a small phase 1 trial.

The phase 3 NuTide:121 trial examining the first-in-class nucleotide analogue NUC-1031 in combination with cisplatin vs gemcitabine plus cisplatin in patients with advanced biliary tract cancer is being discontinued.

The FDA has placed a partial clinical hold on the phase 1 NEON-2 trial examining the combination of davoceticept and pembrolizumab in patients with advanced solid tumors or lymphoma.

Poziotinib elicited encouraging responses when given at a daily dose of 16 mg in the first-line treatment of patients with non–small cell lung cancer with HER2 exon 20 insertion mutations.