Ruxolitinib

Palbociclib + standard therapy improved progression-free survival in hormone receptor–positive, HER2-positive metastatic breast cancer. No significant overall survival benefit observed among CDK4/6 inhibitor combinations in hormone receptor-positive/HER2-negative breast cancer. Patritumab deruxtecan showed similar efficacy to multiagent chemotherapy in high-risk hormone receptor-positive, HER2-negative breast cancer. Ciltacabtagene autoleucel achieved 100% complete response in high-risk smoldering multiple myeloma. Selinexor + ruxolitinib showed efficacy in myelofibrosis patients previously treated with ruxolitinib.

Incyte presents 20 oncology data presentations at 2024 ASH Annual Meeting, including Phase 3 inMIND study results on tafasitamab in follicular lymphoma. Hosts virtual analyst and investor event on December 12, 2024.

Incyte pauses Phase 2 study of INCB000262 due to toxicology findings, and scraps INCB000547 after Phase 2 results. These setbacks impact Incyte's diversification efforts from Jakafi, which faces competition and patent issues. Investors focus shifts to povorcitinib's Phase 3 readout for hidradenitis suppurativa.

Combination of ruxolitinib and low-dose Peg-IFN-α2a in newly diagnosed PV patients showed increased cell counts, decreased JAK2 V617F VAF, and acceptable toxicity. 52% and 56% ORR at 12 and 24 months, respectively. 52% and 68% overall MR at 12 and 24 months. Median JAK2 V617F VAF decreased from 47% to 7% after 2 years. BMHR in 20% and 16% at 12 and 24 months. Normal spleen in all patients after 24 months. Study supports long-term clinical effect of this therapy.

A US district court granted an injunction to Incyte, delaying Sun Pharma's Leqselvi launch for alopecia areata. Sun Pharma plans to appeal, as Leqselvi, a JAK 1/2 inhibitor, competes with Incyte's Olumiant. Incyte claims Leqselvi infringes on its patent for ruxolitinib, a JAK inhibitor.

Keros Therapeutics Inc. (KROS) to update on phase II trials of Elritercept for ineffective hematopoiesis in MDS and MF this quarter. Elritercept shows potential to increase RBC and platelet production, with durable transfusion independence in lower-risk MDS and broader clinical benefits in MF. Additional data expected in Q4 2024. Keros also has Cibotercept in phase II for pulmonary arterial hypertension and KER-065 in phase I for obesity and neuromuscular disorders.

JAK inhibitors are key drugs for treating inflammatory diseases and cancer, with billions in revenue. They target JAK enzymes, crucial for cytokine signaling, reducing inflammation and symptoms. Approved for atopic dermatitis, ulcerative colitis, rheumatoid arthritis, psoriasis, and alopecia areata, they offer significant benefits. For cancer, they treat myelofibrosis and are being explored in combinations with immune checkpoint inhibitors. Safety concerns led to FDA and EMA restrictions, but market growth is expected due to rising autoimmune disease prevalence.

Discussion on posttransplant follow-up, chronic GVHD monitoring, ruxolitinib efficacy, treatment choices for steroid-refractory GVHD, and the role of ECP in managing GVHD, emphasizing collaboration between transplant centers and referring physicians.

Graft versus Host Disease Market to grow at 9.9% CAGR (2020-2034), driven by branded therapies, strong pipeline, and increased awareness. Market size in the US was $1 billion in 2023, expected to grow at 7.4% CAGR (2024-2034). Emerging therapies like Axatilimab and CSL964 to transform market. Key companies include Equillium, Biocon, Takeda, and CSL Behring.