Phase 1/2 Data Combining Urelumab with Opdivo (Nivolumab) in Hematologic and Solid Tumors Suggest Increased Antitumor Effect in Patients with Melanoma

Excerpt:

Bristol-Myers Squibb Company BMY -0.86% today announced safety and efficacy data from a Phase 1/2 study of urelumab in combination with Opdivo (nivolumab) in patients with hematologic and solid tumors, including biomarker analyses by level of PD-L1 expression. The combination of urelumab and Opdivo showed encouraging efficacy among 46 evaluable melanoma patients with an objective response rate (ORR) of 50% (23/46 with 18 confirmed and 5 unconfirmed). ORR was a secondary endpoint as measured by Response Evaluation Criteria In Solid Tumors (RECIST). Similar response was seen in both PD-L1 positive and PD-L1 negative melanoma patients, with ORR of 50% (10/20) and 47% (8/17) in those with greater-than or equal to 1% and <1% PD-L1 expression, respectively. Among the other cohorts (n=78), one non-small cell lung cancer (NSCLC) patient and one squamous cell carcinoma of the head and neck (SCCHN) patient had an objective response. In the full patient population (n=138), no significant added toxicity was observed with urelumab in combination with Opdivo over Opdivo monotherapy. These data were presented at an oral presentation (poster number 239) at the Society for Immunotherapy of Cancer (SITC) 31 Annual Meeting on November 12 at 10:40 a.m. EST in National Harbor, Maryland.”

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Immunotherapy, MEK Inhibitor Combo Effective for BRAF Wild-Type Melanoma

Excerpt:

“The combination of atezolizumab (Tecentriq) and cobimetinib (Cotellic) may lead to a higher overall response (ORR) and a longer progression-free survival (PFS) than either agent alone in patients with metastatic melanoma, according to findings presented at the 2016 Society for Melanoma Research (SMR) Annual Meeting.

“The findings were part of a phase Ib dose-escalation and dose-expansion study, which looked at the PD-L1 inhibitor and MEK inhibitor together in advanced solid tumors. Data on a cohort of 22 patients with ocular melanoma (n = 2) and non-ocular melanoma (n = 20) was presented at the meeting. Among patients in the non-ocular cohort, the ORR was 45% and the disease-control rate (complete response, partial response, and stable disease) was 75%. Median PFS was 12 months (95% CI, 2.8-16.7).”

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COLUMBUS Trial: Binimetinib plus Encorafenib Improves PFS in BRAF–Mutant Melanoma

Excerpt:

“The phase 3 COLUMBUS trial, designed to evaluate binimetinib plus encorafenib for the treatment of BRAF–mutant melanoma, met its primary endpoint of improving PFS over vemurafenib, according to the drug’s manufacturer.

“These results also were presented at the Society for Melanoma Research Congress in Boston.

“In part 1 of the trial, researchers randomly assigned 577 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600mutations to receive 45 mg binimetinib (MEK162, Array BioPharma) plus 450 mg of encorafenib (LGX818, Array BioPharma), 300 mg encorafenib monotherapy or 960 mg vemurafenib (Zelboraf, Genentech) monotherapy.”

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Atezolizumab Combos Highly Effective for Advanced Melanoma

Excerpt:

“The addition of the PD-L1 inhibitor atezolizumab (Tecentriq) to the MEK inhibitor cobimetinib (Cotellic) and the BRAF inhibitor vemurafenib (Zelboraf) induced a high response rate for patients with BRAF-mutant unresectable melanoma, according to findings from a phase Ib study presented at the 2016 Society for Melanoma Research Annual Meeting.

“At the data cutoff of June 15, 2016, 30 patients had received ≥1 dose of atezolizumab. The response rate with the triplet was 83%, which included 3 complete responses (10%) and 21 partial responses. Overall, 29 of the 30 patients were evaluable for response, with just 1 patient experiencing primary progressive disease. At the time of the analysis, median duration of response and progression-free survival were not yet reached.”

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FDA Grants Ribociclib Priority Review for Frontline HR+/HER2

Excerpt:

“The FDA granted a priority review to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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Cabazitaxel/Abiraterone Combination Promising in mCRPC

Excerpt:

“The combination of cabazitaxel and abiraterone was well tolerated and showed antitumor activity in previously treated patients with metastatic castration-resistant prostate cancer (mCRPC), according to a new phase I/II study.

” ‘Therapeutic options for men with mCRPC have evolved considerably with the approval of five therapies associated with improved overall survival,’ wrote study authors led by Christophe Massard, MD, PhD, of Gustave Roussy Cancer Campus in Villejuif, France. Still, ‘there is a need to provide robust evidence on how these agents should be used, in sequence or in combination, to achieve optimal medical management.’ ”

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War of the Checkpoint Inhibitors: Anti-PD-1 Drugs Move into First-Line Treatment in NSCLC


Last year, the U.S. Food and Drug Administration (FDA) approved two anti-PD-1 checkpoint inhibitors, a type of immunotherapy, for treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has progressed after first-line treatment with chemotherapy. Now, the manufacturers of both drugs, pembrolizumab (made by Merck) and nivolumab (made by Bristol-Myers Squibb; BMS) are intent on expanding the indications for use of their drugs. To this end, they have conducted clinical trials testing each as a first-line treatment (i.e., in previously untreated patients), comparing them to standard chemotherapy. Continue reading…


FDA Gives Ribociclib Priority Review for Frontline HR+/HER2- Breast Cancer

Excerpt:

“The FDA has granted priority review designation to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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Entinostat Anchors New Combo in HR+ Breast Cancer Study

Excerpt:

“A dual approach to overcoming resistance to endocrine therapy in patients with advanced hormone receptor (HR)–positive breast cancer is under investigation in a phase III trial that adds the novel drug entinostat to standard exemestane therapy after disease progression.

“The combination has generated excitement in the oncology drug development field after demonstrating an 8-month overall survival (OS) benefit over exemestane alone in the phase II ENCORE 301 study. Those positive results prompted the FDA to grant a breakthrough therapy designation to entinostat in this setting.”

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