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Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)
Enrollment: 141
Study Start Date: March 2014
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
More
Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02038036?term=RESPONSE+2&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Jakafi (Ruxolitinib) (INCB-18424) (oral) PVHemamtologyPolycythemia VeraJanus-associated Kinase InhibitorsJanus-associated Kinase

Mechanism of action: Jakafi (Ruxolitinib) (INCB-18424), a SM-inhibitor, reduces cell proliferation by disrupting the signaling of the Janus-associated kinases (JAK) pathway. Aberrant activation of the JAK-STAT pathway has been documented in a variety of cancers.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-01-01 - 2016-06-30

Results:

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New Phase 3 Data Show Jakafi® (ruxolitinib) is Superior to Best Available Therapy in Patients with Polycythemia Vera (PV)
62 percent of PV patients treated with Jakafi achieved hematocrit control without phlebotomy, compared to 18 percent of patients treated with best available therapy
RESPONSE-2 data complements previous findings from RESPONSE, reinforcing Jakafi is effective in PV patients with or without an enlarged spleen
WILMINGTON, Del.--(BUSINESS WIRE)--Jun. 10, 2016-- Incyte Corporation (Nasdaq: INCY) today announced new 28-week data from the Phase 3 RESPONSE-2 study of Jakafi® (ruxolitinib). The data show that Jakafi was superior to best available therapy (BAT) in maintaining hematocrit control (62.2% vs. 18.7%, respectively; P<0.0001)1 without the need for phlebotomy in patients with inadequately controlled polycythemia vera (PV) resistant to or intolerant of hydroxyurea (HU) who did not have an enlarged spleen. The safety profile of Jakafi was consistent with previous studies. These findings were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.
In RESPONSE-2, patients did not have an enlarged spleen, as assessed by physical examination at each study visit (spleen palpation), and a majority (70%) were previously treated with HU only, therefore considered to have less advanced disease. The remaining patients were treated with multiple lines of therapy (30%).1
“We are pleased with the RESPONSE-2 study results presented at EHA, which reinforce the superiority of Jakafi over best available therapy in achieving hematocrit control, without phlebotomy, in patients with inadequately controlled PV without enlarged spleens,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “These results are meaningful to patients with uncontrolled PV who have few other treatment options to help manage their disease.”
Additionally, the RESPONSE-2 study demonstrated that nearly five times more patients with PV achieved complete hematologic remission with Jakafi compared to BAT at 28 weeks (23.0% vs 5.3% respectively, p=0.0019). Patients taking Jakafi also experienced improvement in their PV symptoms compared to BAT (50% vs 7.7%, respectively). Overall, Jakafi was well tolerated. Findings from this study are consistent with data from the RESPONSE pivotal trial, which evaluated patients with inadequately controlled PV with an enlarged spleen.1,2
“A key treatment goal for patients with PV is to achieve and maintain hematocrit control, and compared to best available therapy, these results from the RESPONSE-2 study demonstrate the clinical benefits of Jakafi in PV patients with less advanced disease,” said lead study investigator Francesco Passamonti, M.D., the University of Insubria, Varese, Italy. “The results from RESPONSE-2, coupled with the previously reported results, support Jakafi as a second-line treatment option for patients with PV.”
More
Source: press release, 6/10/16. http://www.incyte.com/ir/press-releases.aspx

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New Phase 3 Data Show Jakafi® (ruxolitinib) is Superior to Best Available Therapy in Patients with Polycythemia Vera (PV)
62 percent of PV patients treated with Jakafi achieved hematocrit control without phlebotomy, compared to 18 percent of patients treated with best available therapy
RESPONSE-2 data complements previous findings from RESPONSE, reinforcing Jakafi is effective in PV patients with or without an enlarged spleen
WILMINGTON, Del.--(BUSINESS WIRE)--Jun. 10, 2016-- Incyte Corporation (Nasdaq: INCY) today announced new 28-week data from the Phase 3 RESPONSE-2 study of Jakafi® (ruxolitinib). The data show that Jakafi was superior to best available therapy (BAT) in maintaining hematocrit control (62.2% vs. 18.7%, respectively; P<0.0001)1 without the need for phlebotomy in patients with inadequately controlled polycythemia vera (PV) resistant to or intolerant of hydroxyurea (HU) who did not have an enlarged spleen. The safety profile of Jakafi was consistent with previous studies. These findings were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.
In RESPONSE-2, patients did not have an enlarged spleen, as assessed by physical examination at each study visit (spleen palpation), and a majority (70%) were previously treated with HU only, therefore considered to have less advanced disease. The remaining patients were treated with multiple lines of therapy (30%).1
“We are pleased with the RESPONSE-2 study results presented at EHA, which reinforce the superiority of Jakafi over best available therapy in achieving hematocrit control, without phlebotomy, in patients with inadequately controlled PV without enlarged spleens,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “These results are meaningful to patients with uncontrolled PV who have few other treatment options to help manage their disease.”
Additionally, the RESPONSE-2 study demonstrated that nearly five times more patients with PV achieved complete hematologic remission with Jakafi compared to BAT at 28 weeks (23.0% vs 5.3% respectively, p=0.0019). Patients taking Jakafi also experienced improvement in their PV symptoms compared to BAT (50% vs 7.7%, respectively). Overall, Jakafi was well tolerated. Findings from this study are consistent with data from the RESPONSE pivotal trial, which evaluated patients with inadequately controlled PV with an enlarged spleen.1,2
“A key treatment goal for patients with PV is to achieve and maintain hematocrit control, and compared to best available therapy, these results from the RESPONSE-2 study demonstrate the clinical benefits of Jakafi in PV patients with less advanced disease,” said lead study investigator Francesco Passamonti, M.D., the University of Insubria, Varese, Italy. “The results from RESPONSE-2, coupled with the previously reported results, support Jakafi as a second-line treatment option for patients with PV.”
More
Source: press release, 6/10/16. http://www.incyte.com/ir/press-releases.aspx

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Phase 3 RESPONSE-2 Study of Jakafi® (ruxolitinib) Meets Primary Endpoint

Patients with polycythemia vera without enlarged spleen treated with Jakafi achieved hematocrit control without phlebotomy

WILMINGTON, Del.--(BUSINESS WIRE)--Dec. 5, 2015-- Incyte Corporation (Nasdaq:INCY) announces the Phase 3 RESPONSE-2 study of Jakafi® (ruxolitinib) met its primary endpoint. Treatment with Jakafi achieved hematocrit control without the need for phlebotomy in patients with inadequately controlled polycythemia vera (PV) resistant to or intolerant of hydroxyurea (HU) who did not have an enlarged spleen, compared to best available therapy (BAT). The safety profile of ruxolitinib was consistent with previous studies.
"The results from the RESPONSE-2 study demonstrate the clinical benefits of treatment with Jakafi in PV patients without enlarged spleens,” said Rich Levy, MD, Chief Drug Development Officer, Incyte. “We look forward to further analysis of the safety and efficacy data and to sharing the results with the scientific community and regulatory authorities in the coming months.”
More
Source: press release, 12/05/15. http://incyte.com/press-releases/

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