Kristi Rosa

Devimistat, which is being evaluated in combination with modified FOLFIRINOX in the frontline treatment of patients with metastatic adenocarcinoma of the pancreas, failed to meet the primary end point of overall survival in the phase 3 AVENGER 500 trial.

The FDA has granted an accelerated approval to asciminib for patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase who have previously been treated with 2 or more TKIs, and for those with Ph-positive CML in chronic phase with a T315I mutation.

The clinical-stage immunotherapy company PDS Biotechnology Corporation has announced the temporary suspension of recruitment to the National Cancer Institute–led phase 2 trial, which is evaluating a novel triplet combination comprised of PDS0101 and 2 immunomodulating agents in patients with advanced human papillomavirus cancers.

The FDA has granted a priority review to tisagenlecleucel for use in adult patients with relapsed or refractory follicular lymphoma.

Treatment with the next-generation anthracycline annamycin was found to result in preliminary clinical activity without dose-limiting toxicities in patients with soft tissue sarcoma lung metastases.

The administration of NBTXR3 monotherapy activated by radiotherapy resulted in encouraging survival improvements in difficult-to-treat elderly and frail patients with locally advanced head and neck squamous cell carcinoma who are ineligible for cisplatin and intolerant to cetuximab.

The FDA has granted a fast track designation to the interleukin-2 variant immunotherapy nemvaleukin alfa for use in combination with pembrolizumab in the treatment of patients with platinum-resistant ovarian cancer.

The FDA has granted a fast track designation to the universal cancer vaccine UV1 for use in combination with checkpoint inhibitors in patients with unresectable or metastatic melanoma, either as an add-on therapy to pembrolizumab or to ipilimumab.

Although the addition of eryaspase to chemotherapy improved overall survival over chemotherapy alone in patients with metastatic pancreatic cancer, the difference in benefit was not found to be statistically significant, missing the primary end point of the phase 3 TRYbeCA-1 trial.

The combination of durvalumab and chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone when used in the first-line treatment of patients with advanced biliary tract cancer, meeting the primary end point of the phase 3 TOPAZ-1 trial.

Canakinumab plus pembrolizumab and platinum-based doublet chemotherapy did not significantly improve progression-free survival or overall survival in previously untreated patients with locally advanced or metastatic non–small cell lung cancer, missing the primary end points of the phase 3 CANOPY-1 trial.

The immuno-oncology company Agenus has made the decision to withdraw its biologic license application for the use of the PD-1 inhibitor balstilimab in patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.

Oncopeptides AB has made the decision to withdraw the indication of melphalan flufenamide in combination with dexamethasone in select adult patients with relapsed or refractory multiple myeloma from the US market.

The frontline combination of trifluridine/tipiracil and bevacizumab was not found to result in a significant improvement in progression-free survival over capecitabine and bevacizumab in patients with unresectable metastatic colorectal cancer who are not eligible to receive intensive therapy, missing the primary end point of the phase 3 SOLSTICE trial.

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The FDA has approved the VENTANA PD-L1 assay to assist in identifying which adult patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on 1% or more of tumor cells are eligible to receive adjuvant atezolizumab following surgery and platinum-based chemotherapy.

Treatment with the small molecule oral immunomodulator EC-18 resulted in a reduction in both the duration and incidence of severe oral mucositis in patients with head and neck cancer who are undergoing concurrent chemoradiation.

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

Elacestrant monotherapy improved progression-free survival over standard-of-care (SOC) treatment in patients with estrogen receptor–positive, HER2-negative breast cancer, including those whose tumors harbored ESR1 mutations, meeting the primary end points of the phase 3 EMERALD trial.

Intravesical Bacillus Calmette–Guérin in combination with N-803 resulted in a 12-month disease-free survival rate of 57% in patients with BCG-unresponsive high-grade papillary non–muscle invasive bladder cancer, meeting the primary end point for cohort B of the phase 2/3 QUILT 3.032 trial.

The dismutase mimetic avasopasem manganese was not found to significantly reduce the incidence of severe oral mucositis in patients with locally advanced head and neck cancer who were receiving standard-of-care radiotherapy, missing the primary end point of the phase 3 ROMAN trial.

The bicycle toxin conjugates BT5528 and BT8009 have showcased preliminary signs of antitumor activity and encouraging tolerability when administered to patients with solid tumors such as urothelial cancer and ovarian cancer.

Inguinofemoral radiotherapy could potentially spare patients with vulvar cancer and sentinel node micrometastases from the morbidity of a lymphadenectomy.

The FDA has granted an orphan drug designation to LAVA-051, a CD1d-targeted Gammabody, for the treatment of patients with chronic lymphocytic leukemia.

The combination of sintilimab, a bevacizumab biosimilar injection, and chemotherapy resulted in a significant improvement in progression-free survival in patients with EGFR-mutated, nonsquamous, non–small cell lung cancer that as progressed following treatment with an EGFR TKI, meeting the primary end point of the phase 3 ORIENT-31 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding approval of the combination of pembrolizumab and lenvatinib for 2 indications: select patients with renal cell carcinoma and select patients with endometrial carcinoma.

A single, high priming dose of tremelimumab plus durvalumab resulted in a statistically significant and clinically meaningful improvement in overall survival vs sorafenib when used in the frontline treatment of patients with unresectable hepatocellular carcinoma who had not previously received systemic therapy and were not eligible for localized treatment.

The FDA has approved atezolizumab for use as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.

The FDA has approved the Ki-67 IHC MIB-1 pharmDx test to assist in determining which patients with early breast cancer who are at high risk of disease recurrence might benefit from adjuvant treatment with abemaciclib plus endocrine therapy.

The European Medicines Agency has approved a shorter, 90-minute infusion time for obinutuzumab to be given in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma.