FDA Grants Fast Track Designation to CUE-101 ± Pembrolizumab for HPV16+ Advanced HNSCC
October 4th 2022CUE-101 alone or in combination with pembrolizumab was granted fast track designation by the FDA for patients with human papillomavirus 16–positive recurrent/metastatic head and neck squamous cell carcinoma.
Additional Studies Needed for Immunotherapy Combinations in Clear Cell Ovarian Carcinoma
October 3rd 2022Despite inconclusive efficacy results regarding the use of pembrolizumab plus epacadostat in patients with recurrent clear cell ovarian carcinoma, rapid accrual to the trial reveals an unmet need in this cancer subset.
Phase 3 TRITON3 Trial Meets Primary End Point of Radiographic PFS With Rucaparib for mCRPC
October 3rd 2022Results from the phase 3 TRITON3 trial demonstrated that radiographic progression-free survival was significantly improved when patients with metastatic castration-resistant prostate cancer were treated with rucaparib monotherapy vs physician’s choice.
PSA Levels at 8 Months Predict Survival Outcomes With ADT Combinations in mCRPC
October 3rd 2022A recent analysis of data from the phase 3 PEACE-1 study reveals a correlation between 8-month prostate-specific antigen levels and survival outcomes in patients with metastatic castration-sensitive prostate cancer who are treated with systemic therapy regimens that include androgen deprivation therapy.
Pembrolizumab Granted 4 Approvals in Japan for High-Risk TNBC, RCC, and More
October 2nd 2022Japan’s Ministry of Health, Labor and Welfare approved pembrolizumab for use in 4 indications, including high-risk, early-stage triple-negative breast cancer, stage IIB or IIC melanoma, adjuvant renal cell carcinoma, and recurrent/metastatic cervical cancer.
Early Data Show Clinical Benefit With Gavocabtagene Autoleucel in Advanced Solid Tumors
October 1st 2022Treatment with gavocabtagene autoleucel demonstrated efficacy and tolerability in patients with mesothelin-expressing solid tumors, according to updated data from an ongoing phase 1/2 clinical trial.
Quality of Life Sustained With Maintenance Olaparib Rechallenge in Platinum-Sensitive Ovarian Cancer
September 30th 2022Patient-reported outcome data from the phase 3b OReO/ENGOT-ov38 trial showed no significant effect on quality of life following rechallenge with maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer.
Durvalumab Plus CRT Fails to Meet PFS End Point in High-Risk Locally Advanced Cervical Cancer
September 30th 2022Results from the phase 3 CALLA trial indicated that durvalumab in combination with chemoradiotherapy did not yield a meaningful improvement in progression-free survival compared with chemoradiotherapy alone in high-risk locally advanced cervical cancer.
First-Line Tremelimumab ± Durvalumab Misses ORR End Point in Biliary Tract Cancer
September 30th 2022Results from the phase 2 IMMUCHEC trial indicated that tremelimumab with or without durvalumab did not meet the primary end point of improved objective response rate vs chemotherapy in patients with treatment-naïve biliary tract cancer.
FORE8394 Granted Fast Track Designation by FDA for Cancers With Class 1/2 BRAF Alterations
September 29th 2022FORE8394, which received fast track designation by the FDA, is under ongoing evaluation in a phase 1/2a trial in patients with advanced solid and central nervous system tumors harboring BRAF alterations.
Despite Improving Responses, Pembrolizumab/Olaparib Fails to Improve Survival in mCRPC
September 29th 2022Results from the phase 3 KEYLYNK-010 study showed that treatment with pembrolizumab and olaparib did not result in a statistically significant improvement in survival despite yielding higher responses compared with novel hormonal agents in patients with previously treated prostate cancer.