Incyte to present at ASCO meeting in Chicago

Incyte announces abstracts featuring genomic profiling data for ASCO

Incyte Corp. (INCY) announces that multiple abstracts highlighting data from its oncology portfolio will be presented at the upcoming 2019 American Society of Clinical Oncology Annual Meeting, to be held from May 31-June 4, in Chicago, Illinois; and the 24th Congress of the European Hematology Association, to be held June 13-16, in Amsterdam, the Netherlands.

Abstracts accepted for presentation at ASCO feature genomic profiling data from Incyte’s ongoing Phase 2 FIGHT-202 trial evaluating its selective fibroblast growth factor receptor inhibitor, pemigatinib, in patients with cholangiocarcinoma, as well as efficacy and safety data from the Novartis-sponsored GEOMETRY mono-1 trial of capmatinib, the investigational selective MET inhibitor licensed to Novartis (NVS) by Incyte.

Additionally, data to be presented at EHA will showcase the continued study of Incyte’s JAK1/JAK2 inhibitor, #ruxolitinib, in myeloproliferative neoplasms.

“Our presence at ASCO and EHA illustrates Incyte’s ongoing commitment to discovering and developing therapeutic options that address significant unmet medical needs for patients,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

ASCO’s annual meeting is May 31-June 4 in Chicago, Stockwinners

“We are pleased to highlight new data on two investigational medicines – pemigatinib and capmatinib – that were discovered by Incyte scientists and for which we anticipate applications for initial U.S. regulatory approvals later this year, as well as data that furthers our understanding of the treatment of MPNs.”

Incyte Corporation focuses on the discovery, development, and commercialization of various therapeutics in the United States. The company offers JAKAFI, a drug for the treatment of myelofibrosis and polycythemia vera cancers; and Iclusig, a kinase inhibitor to treat chronic myeloid leukemia and philadelphia-chromosome positive acute lymphoblastic leukemia.

Its clinical stage products include ruxolitinib, a drug in Phase III clinical trial for steroid-refractory acute graft-versus-host-diseases (GVHD); and Phase II trial for the treatment of essential thrombocythemia and refractory myelofibrosis.

In addition, the company engages in the development of itacitinib, which is in Phase III clinical trial to treat naïve acute and chronic GVHD, as well as Phase I/II clinical trial in combination with osimertinib for non-small cell lung cancer (NSCLC); and pemigatinib that is in Phase II clinical trial for treating bladder cancer, cholangiocarcinoma, and 8p11 myeloproliferative syndrome, as well as a pivotal program for solid tumors with driver activations of FGF/FGFR.

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TG Therapeutics’ Leukemia Drug Proves Effective

Adding TG-1101 to ibrutinib increased the number of patients with bone marrow confirmed CR’s, MRD negativity

The combination was well tolerated; the addition of TG-1101 did not appear to alter the safety profile of ibrutinib monotherapy

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American Society of Clinical Oncology’s #ASCO Annual Meeting is taking place June 2 to June 6 in Chicago. Several pharmaceutical firms and biotechnology companies are presenting their new drugs and/or present progress on the status of their drugs under development. TG Therapeutics is one of those companies.

#TG Therapeutics $TGTX announced positive results from its Phase 3 $GENUINE trial of #TG-1101 plus ibrutinib in patients with previously treated high risk Chronic #Lymphocytic #Leukemia.
The trial was powered to show a statistically significant improvement in ORR of 30%, with a minimal absolute detectable difference between the two arms of approximately 20%. The trial met its primary endpoint, demonstrating a statistically significant improvement in Overall Response Rate, as assessed by blinded independent central radiology and hematology review by iwCLL criteria, compared to ibrutinib alone in both the Intent to Treat population and Treated population.
The combination was well tolerated and, apart from infusion related reactions, the addition of TG-1101 did not appear to alter the safety profile of ibrutinib monotherapy.
#Neutropenia, occurring in 9% of patients, was the most commonly reported Grade 3/4 Adverse Event in the combination arm, followed by infusion related reactions and #anemia, each reported in 5% of patients.
Neutropenia or #neutropaenia, is an abnormally low concentration of neutrophils (a type of white blood cell) in the blood. Neutrophils make up the majority of circulating white blood cells and serve as the primary defense against infections by destroying bacteria, bacterial fragments and immunoglobulin-bound viruses in the blood.  Patients with neutropenia are more susceptible to bacterial infections and, without prompt medical attention, the condition may become life-threatening.
Notably, the majority of infusion related reactions were Grade 1 or 2 in severity, with only 5% Grade 3/4 IRR observed. Median follow-up for this study was approximately 11.4 months.
In addition to the improvements in ORR, CR and MRD-negativity, a trend in improvement of Progression Free Survival was observed in the combination arm of TG-1101 plus ibrutinib as compared to ibrutinib alone.
“In addition to increasing the overall number of patients that responded to treatment with ibrutinib, adding TG-1101 to ibrutinib increased the number of patients with bone marrow confirmed CR’s, MRD negativity in peripheral blood, deepened nodal responses, and resulted in fewer patients progressing on therapy. Collectively, we see the consistent pattern of enhanced benefit as providing a compelling case for combining TG-1101 with ibrutinib in these hard to treat patients with high-risk CLL. We look forward to sharing these data with the FDA later this year to discuss filing for accelerated approval,” the company noted.

Other stocks to watch in the group: $INCY, $TSRO, $AZN, $AMGN

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Merck’s Breast Cancer Drug Proves Effective

The NYU’s Langone Medical Center announced that Merck’s pembrolizumab has been found to be effective in patients with metastatic triple negative breast cancer

The most common side effects in both patient populations were fatigue and nausea

 

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American Society of Clinical Oncology’s #ASCO Annual Meeting is taking place June 2 to June 6 in Chicago. Several pharmaceutical firms and biotechnology companies are presenting their new drugs and/or present progress on the status of their drugs under development. Merck is one of those companies.

The New York University’s Langone Medical Center announced that #Merck’s #pembrolizumab has been found to be effective in patients with metastatic triple negative breast cancer, according to an international clinical trial led by the center.

The trial investigated the drug in two separate cohorts of patients: Cohort A, which included 170 patients with heavily pretreated metastatic triple negative breast cancer regardless of PD-L1 expression, and Cohort B, which included 52 patients with PD-L1-positive tumors who received it as first-line therapy.

In #Cohort A, pembrolizumab shrunk tumors by more than 30 percent in eight of 170 patients, or five percent, and stabilized the disease in 35, or 21 percent, of those previously treated for mTNBC. Of the eight who experienced tumor reduction, all of them lived at least another year. The remaining patients in this cohort had a lower chance of survival.

In Cohort B-those who received pembrolizumab as first-line therapy-12 of 52 patients, or 23 percent, saw tumors shrink by more than 30 percent, while the disease was stabilized in nine of them, or 17 percent.

Study presenter Sylvia Adams pointed out that Cohort A is the first phase II study of an immunotherapy for triple negative breast cancer to be reported and represents the largest cohort of patients with mTNBC treated with immunotherapy to date.

“The goals of Cohort B, for which survival data are not yet complete, were, primarily, to prove pembrolizumab’s safety and, secondarily, to explore its efficacy as a first-line treatment. Both goals appear to have been met,” the center said.

Merck $MRK funded this clinical trial.

Pembrolizumab, marketed under the name #Keytruda, was well tolerated by both cohorts at a 200mg dose every three weeks, according to study results.

Only 12 percent of patients in Cohort A experienced severe side effects and only eight percent experienced them in Cohort B.

The most common side effects in both patient populations were fatigue and nausea. Although side effects led to discontinuation of treatment in seven patients from Cohort A, no patients in Cohort B discontinued treatment due to adverse side effects.

Other stocks to watch in the group: $INCY, $TSRO, $PBYI, $AMGN

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The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.