Renal cell cancer vaccines
Immatics Biotechnologies' cancer vaccine IMA901 is currently in phase III trials for the first-line treatment of metastatic renal cell cancer. The drug, which was shown to have a positive safety profile in its single-arm Phase II trial, is expected to gain approval in the US and five major EU markets* by 2015. It's estimated that IMA901 will be worth $88m by 2022, but is likely to face competition from Argos therapeutics/Kyowa HakkoKirin's AGS-003 which is currently at the same stage of development.
Although both IMA901 and AGS-003 have shown promising clinical efficacy, some physicians are still sceptical about the use of vaccines for the first-line treatment of metastatic disease. The characteristics of patients in this treatment setting make positive outcomes to therapeutic vaccination less likely than in early-stage disease.
Polynoma/CK Life Sciences are in the process of developing POL-103A, an adjuvant treatment that is administered following the complete resection of malignant melanoma. The drug is expected to launch in 2017 and is forecast to be worth $37m by 2022.
GlaxoSmithKline (GSK) announced earlier this month that its cancer vaccine MAGE-A3 did not meet the first co-primary endpoint of its pivotal Phase III DERMA trial. GSK is continuing the DERMA trial in order to identify a subset of MAGE-A3 positive patients that may benefit from the treatment.
Dr Aine Slowey, analyst at Datamonitor Healthcare said: "Despite the relatively high cost associated with the development of cancer vaccines, they remain of commercial interest because of their potential to elicit longer responses in patients without the significant toxicity associated with conventional approaches".
"POL-103A has shown to have good tolerability as well as a good safety profile in clinical trials. The drug has also shown moderate efficacy in patients with a particularly high chance of disease recurrence,which may allow to drug to gain uptake in the melanoma market"
"The failure of MAGE-A3 to demonstrate a clinical benefit in MAGE-A3-positive melanoma patients highlights how difficult it is to successfully develop a cancer vaccine and will no doubt be disappointing for GlaxoSmithKline."
"If MAGE-A3 meets the second co-primary endpoint of its Phase III trial, it is possible that the drug will gain approval for the treatment of this restricted subgroup of melanoma patients. However, the need to screen patients for the necessary genetic marker is likely to increase treatment costs and reduce the vaccine's attractiveness, significantly limiting its uptake."