Seviprotimut-L (Polynoma/CK Life Sciences) is a polyvalent, shed-antigen vaccine in development for the adjuvant treatment of Stage IIb–III melanoma patients. Seviprotimut-L contains a combination of antigens from three proprietary melanoma cell lines, and is intended to stimulate the body’s immune system to fight cancer. The combination of antigens increases the chances that the vaccine contains the correct agents to stimulate an immune response against the tumor, and circumvents human leukocyte antigen phenotype restrictions.
CK Life Sciences is positioning seviprotimut-L as an adjuvant therapy following complete resection of Stage IIb, IIc, or III melanoma, but the drug will likely face significant competition in this setting. At present, interferon alfa, Yervoy (ipilimumab; Bristol-Myers Squibb/Ono Pharmaceutical), and Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) are approved for the adjuvant treatment of melanoma, with two more approvals on the horizon: the combination of Tafinlar (dabrafenib; Novartis) and Mekinist (trametinib; Novartis/Japan Tobacco) in the adjuvant setting was granted breakthrough therapy designation in October 2017, and is expected to be approved in 2018; additionally, Keytruda (pembrolizumab; Merck & Co) is in Phase III development in the adjuvant setting, and is also on track to be approved in 2018. To date, only data from the 38-patient Phase II seviprotimut-L clinical trial have been published. However, these results are promising and show that seviprotimut-L prolongs the recurrence-free survival of patients with Stage III resected melanoma with minimal side effects. If these positive results can be reproduced in the ongoing Phase III study, seviprotimut-L could potentially provide oncologists with a less toxic alternative adjuvant therapy.
LIST OF FIGURES
10 Figure 1: Seviprotimut-L for melanoma – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of seviprotimut-L for melanoma
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of seviprotimut-L for melanoma
14 Figure 4: Seviprotimut-L sales for melanoma in the US, 2017–26
LIST OF TABLES
6 Table 1: Seviprotimut-L drug profile
7 Table 2: Seviprotimut-L ongoing late-phase trial in melanoma
9 Table 3: Seviprotimut-L other clinical trials in melanoma
15 Table 4: Seviprotimut-L sales for melanoma in the US ($m), 2017–26
17 Table 5: Seviprotimut-L patient numbers for melanoma in the US, 2017–26
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