Incyte Receives Positive EMA Opinion for Zynyz in SCAC Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4h ago
0mins
Source: Businesswire
- Positive EMA Opinion: Incyte announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for Zynyz (retifanlimab) in combination with platinum-based chemotherapy, marking a significant step towards new treatment options for patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
- Clinical Trial Data: Data from the Phase 3 POD1UM-303/InterAACT2 trial showed that the combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for the placebo group, indicating a statistically significant 37% reduction in the risk of progression or death (P=0.0006), providing new hope for SCAC patients.
- Safety Assessment: Among patients receiving Zynyz in combination with chemotherapy, 47% experienced serious adverse reactions, with the most common being sepsis, pulmonary embolism, diarrhea, and vomiting; however, no new safety signals were identified, indicating an acceptable safety profile for this treatment regimen.
- Market Potential: SCAC accounts for approximately 85% of all anal cancer cases, with a global prevalence estimated at 1 to 2 cases per 100,000 people, and with the potential approval of Zynyz, Incyte is poised to establish a new standard of care in this rare and difficult-to-treat cancer, addressing the urgent market need for innovative therapies.
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Analyst Views on INCY
Wall Street analysts forecast INCY stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for INCY is 100.31 USD with a low forecast of 73.00 USD and a high forecast of 125.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
19 Analyst Rating
9 Buy
9 Hold
1 Sell
Moderate Buy
Current: 101.080
Low
73.00
Averages
100.31
High
125.00
Current: 101.080
Low
73.00
Averages
100.31
High
125.00
About INCY
Incyte Corporation is a biopharmaceutical company, which is focused on the discovery, development, and commercialization of therapeutics. The Company operates in two therapeutic areas. One therapeutic area is Hematology/Oncology, which is comprised of Myeloproliferative Neoplasms and Graft-Versus-Host Disease, as well as solid tumors and hematologic malignancies. Its other therapeutic area is Inflammation and Autoimmunity, which includes its Dermatology commercial franchise. Its hematology and oncology franchise are comprised of six products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG (ponatinib), NIKTIMVO (axatilimab-csfr), and ZYNYZ (retifanlimab-dlwr), as well as numerous clinical development programs. The Company's pipeline also includes two first-in-class small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and INCB000547, an oral MRGPRX4 antagonist.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Incyte Receives Positive EMA Opinion for Zynyz in SCAC Treatment
- Positive EMA Opinion: Incyte announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for Zynyz (retifanlimab) in combination with platinum-based chemotherapy, marking a significant step towards new treatment options for patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
- Clinical Trial Data: Data from the Phase 3 POD1UM-303/InterAACT2 trial showed that the combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for the placebo group, indicating a statistically significant 37% reduction in the risk of progression or death (P=0.0006), providing new hope for SCAC patients.
- Safety Assessment: Among patients receiving Zynyz in combination with chemotherapy, 47% experienced serious adverse reactions, with the most common being sepsis, pulmonary embolism, diarrhea, and vomiting; however, no new safety signals were identified, indicating an acceptable safety profile for this treatment regimen.
- Market Potential: SCAC accounts for approximately 85% of all anal cancer cases, with a global prevalence estimated at 1 to 2 cases per 100,000 people, and with the potential approval of Zynyz, Incyte is poised to establish a new standard of care in this rare and difficult-to-treat cancer, addressing the urgent market need for innovative therapies.
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Zynyz® Receives Positive Opinion for SCAC Treatment in Europe
- Therapeutic Innovation: Zynyz® (retifanlimab) in combination with platinum-based chemotherapy has received a positive opinion from the EMA's CHMP, marking it as the first PD-1 immunotherapy for advanced squamous cell carcinoma of the anal canal (SCAC) in Europe, which is expected to significantly enhance treatment options for patients.
- Clinical Trial Results: Data from the POD1UM-303/InterAACT2 trial showed that patients receiving Zynyz with platinum-based chemotherapy achieved a median progression-free survival of 9.3 months compared to 7.4 months in the placebo group, indicating a significant 37% reduction in the risk of progression or death, highlighting its therapeutic advantage.
- Market Potential: With SCAC's global prevalence estimated at 1 to 2 cases per 100,000 people, and a higher incidence in women, the approval of Zynyz is poised to fill a critical gap in the treatment landscape for this rare cancer, potentially establishing a new standard of care to meet the urgent demand for innovative therapies.
- Safety Assessment: Among patients treated with Zynyz and chemotherapy, 47% experienced serious adverse reactions, primarily sepsis and pulmonary embolism; however, no new safety signals were identified, indicating an acceptable safety profile for this treatment regimen.
Continue Reading