Continuous Low-Dose Ribociclib Active in Advanced Breast Cancer Causes Less Neutropenia

Excerpt:

“Continuous low-dose ribociclib shows preliminary activity, and has an acceptable safety profile as an alternative to intermittent ribociclib dosing when combined with fulvestrant in the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

“A phase Ib study, presented at the 2016 San Antonio Breast Cancer Symposium, demonstrated a confirmed partial response (PR) of 13.3% in the continuous ribociclib arm, compared with 23.1% in the intermittent ribociclib arm, but a lower rate of high-grade neutropenia in patients receiving continuous dosing of ribociclib.”

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Pfizer Presents Data from Phase 1b Trial Investigating Utomilumab (a 4-1BB agonist) in Combination with a Checkpoint Inhibitor

Excerpt:

“Pfizer Inc. PFE -0.26% today announced results from a Phase 1b trial of Pfizer’s investigational immunotherapy agent utomilumab (the proposed non-proprietary name for PF-05082566), a 4-1BB (also called CD137) agonist, in combination with pembrolizumab, a PD-1 inhibitor, in patients with advanced solid tumors. This is the first reported study of a 4-1BB agonist combined with a checkpoint inhibitor. Encouraging safety data from the study were shared today as an oral presentation at the 52 [nd] Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“ ‘While these are early data, the combination of utomilumab with pembrolizumab demonstrates an encouraging safety profile and an early indication of potential anti-tumor activity across solid tumors,’ said Anthony W. Tolcher, M.D., director of clinical research at South Texas Accelerated Research Therapeutics (START) San Antonio. ‘We believe these results warrant further investigation to confirm whether combining utomilumab with a checkpoint inhibitor may amplify anti-tumor responses.’ ”

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Nivolumab/Ipilimumab Frontline Response Nears 60% in PD-L1+ NSCLC

Excerpt:

“Upfront treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated an objective response rate (ORR) of 57% in patients with PD-L1-positive advanced non–small cell lung cancer (NSCLC), according to updated pooled findings from the phase Ib CheckMate-012 study presented at the 2016 ASCO Annual Meeting.

“In the 3-arm study, patients received nivolumab alone or in combination with ipilimumab every 6 weeks (Q6W) or every 12 weeks (Q12W). Across the full population, which was not selected based on PD-L1 expression, single-agent nivolumab had an ORR of 23%. In the combination arms, the ORRs were 47% and 39%, in the Q12W and Q6W arms, respectively.”

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Expert Discusses Promise of CRS-207 Vaccine in Mesothelioma

Excerpt:

“The investigational cancer vaccine CRS-207 may improve response and survival when given with chemotherapy in patients with malignant pleural mesothelioma (MPM) according to results of a phase Ib trial.

“CRS-207, a live-attenuated, double-deleted Listeria monocytogene engineered to express the tumor-associated antigen mesothelin, was administered with chemotherapy to 38 patients with MPM. Of 34 evaluable patients, 59% (n = 20) had partial response posttreatment and 35% (n = 12) had stable disease, for an overall disease-control rate 94%. Median progression-free survival was 8.5 months and median overall survival had not been reached.

“Immunohistochemistry data from 3 patients revealed an increase in tumor-infiltrating lymphocytes (TILs) post–CRS-207. Treatment-associated changes in circulating immune cells and biomarkers were also observed.”

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Pembrolizumab Promising in Metastatic Triple-Negative Breast Cancer

Excerpt:

“Results from a phase Ib trial suggest that the programmed death 1 (PD-1) inhibitor pembrolizumab has activity and an acceptable toxicity profile as single-agent therapy in heavily pretreated, advanced triple-negative breast cancer (TNBC).

“ ‘TNBC tumors are frequently of high histological grade, present at an advanced stage, are typically more aggressive and difficult to treat than hormone receptor–positive tumors, and are associated with a higher risk of early relapse,’ wrote study authors led by Rita Nanda, MD, of the University of Chicago. ‘Given the suboptimal outcomes with chemotherapy, new targeted therapies for TNBC are urgently needed.’ ”

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Video: Dr. Saeed Rafii on the Phase Ib JAVELIN Trial Examining Avelumab in Breast Cancer

“Saeed Rafii, MD, PhD, MRCP, medical oncologist, medical director, Sarah Cannon Research Institute, London, discusses the phase Ib JAVELIN solid tumor trial. The trial looks at the anti-PD-L1 antibody avelumab (MSB0010718C) in patients with locally advanced or metastatic breast cancer. Rafii said the trial looked at 168 patients, regardless of the subtype of their breast cancer.

“Patients enrolled in the trial must have had 3 or fewer lines of chemotherapy prior to receieving avelumab. Rafii said of the patients, 10% experiences immune-related events. He also added that 8 patients had to stop due to treatment-related toxicities and that there were 2 mortalities. One of the 2 mortalities were from acute hepatic failure and another from respitority distress.”

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Atezolizumab/Nab-Paclitaxel Combo Shows High Response Rates in TNBC

“Upfront treatment with the PD-L1 inhibitor atezolizumab (MPDL3280A) plus nab-paclitaxel (Abraxane) showed a confirmed objective response rate (ORR) of 66.7% in patients with metastatic triple-negative breast cancer (TNBC), according to data presented at the 2015 San Antonio Breast Cancer Symposium.

“In the phase Ib study, atezolizumab plus nab-paclitaxel was explored across several lines of treatment regardless of PD-L1 status for patients with metastatic TNBC. In the second-line setting, the confirmed ORR was 25% and in the third-line and beyond the ORR was 28.6%. Across the full trial, the ORR was 41.7%.

“ ‘For the efficacy, we saw a very high response rate, which is extremely exciting and encouraging,’ said lead investigator Sylvia Adams, MD, associate professor of Medicine, NYU Perlmutter Cancer Center. ‘The combination was well-tolerated without additive toxicity. We saw only toxicity that was predictable for the single agents alone.’ “


Roche Buoyed by Early Data on Atezolizumab in Advanced Melanoma

“Swiss drugmaker Roche released on Monday what it called encouraging early data on cancer drug atezolizumab in combination therapy for treating a form of advanced melanoma.

“A phase Ib study of atezolizumab (MPDL3280A), used in combination with the BRAF inhibitor Zelboraf for previously untreated BRAFV600 mutation-positive inoperable or metastatic melanoma, showed adverse events were “manageable and generally reversible”, it said.

“It showed the combination resulted in an objective response rate of 76 percent of people, including three complete responders.”


T-VEC/Pembrolizumab Combination Demonstrates Safety in Melanoma

“The combination of the attenuated oncolytic virus talimogene laherparepvec (T-VEC) and the immune checkpoint inhibitor pembrolizumab has passed an early safety evaluation for unresectable melanoma, investigators reported at the 2015 European Cancer Congress (ECC).

“Treatment-related grade 3 adverse events occurred infrequently in a small phase Ib trial of combination therapy with T-VEC and pembrolizumab. No patient discontinued treatment because of adverse events and no treatment-related deaths occurred.

“ ‘T-VEC plus pembrolizumab was well tolerated, and we observed no dose-limiting toxicity,’ said Georgina V. Long, BSc, PhD, MBBS, associate professor at the University of Sydney in Australia. ‘Treatment-related adverse events were mostly grade 1/2. The combination of T-VEC and pembrolizumab is feasible and warrants further investigation.’ “