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ASCO conference: Verastem's blood cancer drug shows benefits in extension study

Verastem Inc. said its investigational drug duvelisib showed positive results in an extension of a previous phase 3 study among patients with a certain form of blood cancer.

The original study, also called Duo, compared duvelisib with Genmab A/S and Novartis AG's Arzerra, or ofatumumab, in treating relapsed or therapy-resistant chronic lymphocytic leukemia, or CLL, and small lymphocytic lymphoma, or SLL.

CLL and SLL are slow-growing cancers in which immature lymphocytes, or white blood cells, are found in the blood and bone marrow as well as in the lymph nodes.

In the Duo study, duvelisib showed a statistically significant improvement in keeping the disease at bay, a measure known as progression-free survival, for a median of 13.3 months versus 9.9 months for Arzerra.

The patients whose disease continued to spread after treatment with Arzerra were given the option to receive duvelisib as part of a Duo crossover extension study in which both patients and researchers knew which medicine was being given.

Among 89 evaluable patients who had undergone treatment with an average of three prior therapies, duvelisib showed an effect on the cancer, also called overall response rate, in 73% of the patients.

The extension study also demonstrated a median progression-free survival of 15 months and partial response, or reduction in cancer, in 68% of patients. About 5% of patients showed no signs of cancer following treatment, also called a complete response.

Verastem said that while receiving Arzerra, the same patients had registered a progression-free survival of 9 months, an overall response rate of 28%, a partial response rate of 27% and a complete response rate of 1%.

In another presentation at the American Society of Clinical Oncology meeting, the company revealed a new analysis of data from its Contempo trial in previously untreated patients with follicular lymphoma.

Follicular lymphoma is a non-Hodgkin's lymphoma in which the malignant blood cells can travel to other parts of the body and form tumors in those places.

The study had tested a combination of duvelisib and Roche Holding AG's Rituxan, or rituximab, against another combination of duvelisib and Roche's Gazyva, or obinutuzumab.

Results from the study had shown an overall response rate of 93% and a complete response rate of 36% for the duvelisib plus Rituxan group, compared with an overall response rate of 89% and a complete response rate of 41% for the duvelisib plus Gazyva group.

After comparing several tests from the trial, Verastem confirmed that duvelisib disrupted the function of two enzymes in follicular lymphoma patients by targeting the cellular environment of the tumor. The phosphoinositide 3-kinase, or PI3K-delta and PI3K-gamma, enzymes are known to help support the growth and survival of malignant B cells and T cells.

The Needham, Mass.-based company also reported data from a phase 1 study testing its investigational drug defactinib in combination with Merck & Co. Inc.'s Keytruda and chemotherapy drug gemcitabine, sold as Gemzar by Eli Lilly and Co., in patients with advanced solid tumors.

Of the 15 evaluable patients with various tumor types, one achieved a partial response and eight achieved stable disease, meaning the tumors stopped growing.

Among the eight patients with hard-to-treat pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, one achieved a partial response and three achieved stable disease.

The combination was well tolerated by patients and showed growth in healthy immune cells in patients with controlled disease compared to those with progressive disease.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on site and an additional 3,350 abstracts to be published online.