A pivotal phase II clinical study of cemiplimab, an investigational human antibody targeting PD-1, demonstrated an overall response rate of 46.3% in 82 patients with advanced cutaneous squamous cell carcinoma.
Genentech's phase III IMmotion151 study met its co-primary endpoint ofprogression-free survival and demonstrated that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death in people whose disease expressed the PD-L1 (PD-L1 expression ≥1 percent) protein compared with sunitinib for the first-line treatment of people who have advanced or metastatic renal cell carcinoma.
MURANO, a randomized phase III study sponsored by Abbvie, showed that patients with relapsed or refractory chronic lymphocytic leukemia achieved significantly prolonged median progression-free survival with Venclexta/Venclyxto (venetoclax) in combination with Rituxan (rituximab) [median PFS, not reached], compared with bendamustine in combination with Rituxan [median PFS, 17.0 months; hazard ratio, 0.17; 95% CI, 0.11–0.25; P<0.0001].
Juno Therapeutics Inc., a biopharmaceutical company developing cellular immunotherapies for the treatment of cancer, released additional data from the TRANSCEND study of JCAR017 (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma in a presentation at the 59th American Society of Hematology Annual Meeting and Exposition.
The phase III EMBRACA trial in patients with germline BRCA1/2-positive locally advanced and/or metastatic breast cancer demonstrated superior progression-free survival in patients treated with talazoparib, compared to patients who received physician's choice standard of care chemotherapy.
FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
Ziopharm Oncology Inc. announced positive data updates supporting survival benefit and the underlying immune system mechanism for Ad-RTS-hIL-12 plus veledimex, the company's controlled human interleukin-12 gene therapy candidate for brain cancer, at the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology.
X4 Pharmaceuticals, a clinical stage biotechnology company developing a CXCR4 inhibitor to improve immune cell trafficking to treat cancer and rare diseases, announced updated results from the phase I part of an ongoing phase I/II study of X4P-001-IO in combination with Inlyta (axitinib) in patients with clear cell renal cell carcinoma.
Novartis announced positive topline results from the global MONALEESA-7 trial, the second phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer.
