Steven Stein
Executive Vice President & Chief Medical Officer at Incyte
Thanks Barry and good morning everyone. Starting with ruxolitinib cream, the FDA review of the NDA for ruxolitinib cream in atopic dermatitis is ongoing with a new PDUFA date of September 21. At the Revolutionizing Atopic Dermatitis Conference in June, 52-week data from the TRuE-AD program were presented showing long-term disease control with as needed use of ruxolitinib cream. The majority of subjectivities [Phonetic] clear, almost clear skin by week eight and we saw no new safety signals during the long-term safety period, including no adverse events suggestive of a relationship to systemic exposure. We also recently initiated our Phase 3 pediatric program in an effort to expand the patient populations who might benefit from ruxolitinib cream.
Turning to Slide 14, we previously announced at the beginning of Q2 that the Phase 3 vitiligo program had achieved its primary and key secondary endpoint at week 24. Patients were randomized to receive 1.5% ruxolitinib cream twice daily all vehicle for 24 weeks. At which point a cross-over occurred from vehicle to 1.5% ruxolitinib cream twice daily for an additional 28 weeks. The overall efficacy and safety profile of ruxolitinib cream were consistent with previously reported Phase 2. As a reminder, 30% of patients in the Phase 2 study achieved a F-VASI75 and continued improvement was seen through 52 weeks.
With these positive outcomes we are on track for an sNDA and MAA submissions in the second half of 2021 and are optimistic that ruxolitinib cream maybe a meaningful treatment option for patients living with vitiligo.
On Slide 15, tafasitamab three-year data from the L-MIND study were presented in June at the 2121 American Society of Clinical Oncology Annual Meeting, and subsequently published in the Hematologic in July. These data demonstrated significant durable responses and reaffirmed a consistent safety profile with tafasitamab treatment in patients with relapsed or refractory diffuse large B cell lymphoma who are uneligible for transplant.
We are particularly encouraged by the tolerability and high overall response rates seen especially in the second line setting, which exhibits the importance of starting therapy sooner. In addition, the study demonstrated that subsequent treatment, including an autologous stem cell transplant and CAR-T therapy is not precluded in patients with disease progression during the tafasitamab plus lenalidomide treatment. We are looking forward to the decision from the European Commission following the positive CHMP opinion received in June.
Turning to the next slide, tafasitamab's clinical program continues to develop with multiple pivotal and proof-of-concept studies to start later this year. As of today, there are three updates to the program. The first being frontMIND which is now ongoing and enrolling patients in first line diffuse large B cell lymphoma. Second, the initiation of coreMIND, a pivotal trial evaluating tafasitamab plus parsaclisib in relapsed or refractory chronic lymphocytic leukemia, based on the positive results of the COSMOS study. Lastly, we expect to initiate MINDway, which is our dose optimization study in relapsed or refractory diffuse large B cell lymphoma.
On Slide 17, LIMBER program continues to evolve in a positive way. We presented positive once daily ruxolitinib bioavailability and bioequivalence data at EHA in 2021 which demonstrated bioequivalence for area under the curve. Once daily ruxolitinib stability testing is ongoing and we expect to file an NDA in early 2022. Multiple trials are ongoing, including the potential for fixed dose combinations with parsaclisib plus ruxolitinib, and we anticipate the initiation of the BET and L2 combination components of the irrespective trials of ruxolitinib in the second half of this year.
Turning to Slide 18, the results REACH3 investigated ruxolitinib in steroid refractory chronic graft versus host disease were recently published in the New England Journal of Medicine. This data shows that treatment with ruxolitinib significantly improved overall response rate at week-24, as well as a much higher best overall response rate versus best available therapy. Reach3 also achieved statistically and clinically meaningful improvements in key secondary endpoints, including failure-free survival and symptom response. With a September 22 PDUFA we are excited at the potential to help bring this therapy to patients living with steroid refractory chronic graft versus host disease who currently have very limited treatment options.
Turning to parsaclisib on Slide 19, we presented Phase 2 data in autoimmune hemolytic anemia at the EHA in 2021, which showed high response rates and a normalization of hemoglobin levels during the initial 12 week treatment period. Clinically meaningful improvements in fatigue related quality of life were observed and parsaclisib was generally well tolerated. In a disease with no currently approved treatments we continue our commitment to patients through the development of parsaclisib and the initiation of Phase 3 trial to start later this year.
In closing, we had a number of clinical development successes announcing positive data across multiple programs and making significant progress within certain key development programs during the first half of 2021 and we expect an eventful second half with multiple potential approvals and additional regulatory submissions.
With that, I would like to turn the call over to Christiana for the financial update.