Encouraging pipeline could defy cancer
By Mia Burns (firstname.lastname@example.org)
Datamonitor Healthcare is pulling back the curtain on a promising drug pipeline that is expected to have a positive impact on the treatment of renal cell cancer and melanoma. This action follows SMi’s 2nd annual conference on Cancer Vaccines. A challenge for pharma to face is the fact that some physicians are still skeptical about the use of vaccines for the first-line treatment of metastatic disease. The characteristics of patients in such a treatment setting make positive outcomes to therapeutic vaccination less likely than in early-stage disease.
“The benefit from vaccination may not be evident in these late-stage patients as the survival time may not belong enough for the immune system to mount a sufficient response,” says Dr. Áine Slowey, analyst at Datamonitor Healthcare. “Cancer vaccines in development in other indications such as melanoma get around this issue by targeting the adjuvant treatment of earlier stage patients following complete surgical resection of their tumor. The cancer vaccines in development for renal cell cancer are being investigated in combination with Pfizer’s Sutent. The investigators may hope that treatment with Sutent will reduce the risk of disease progression before the appropriate immunotherapy response occurs.”
Immatics Biotechnologies’ cancer vaccine IMA901 is currently in phase III trials for the first-line treatment of metastatic renal cell cancer. Datamonitor Healthcare analysts say that 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 United States and five major European Union markets by 2015. It is estimated that IMA901 will be worth $88 million by 2022, but is likely to face competition from Argos Therapeutics/Kyowa Hakko Kirin’s AGS-003, which is currently at the same stage of development.
As for melanoma vaccines, Polynoma/CK Life Sciences are in the process of developing POL-103A, an adjuvant treatment that is administered after the complete resection of malignant melanoma. The drug is expected to launch in 2017 and is forecast to be worth $37 million by 2022, according to Datamonitor Healthcare. GlaxoSmithKline has announced that its cancer vaccine MAGE-A3 did not meet the first co-primary endpoint of its Phase III Derma trial. GlaxoSmithKline is continuing the Derma trial to identify a subset of MAGE-A3 positive patients that may benefit from the treatment.
Relatively high costs are associated with the development of cancer vaccines. Dr. Slowey told Med Ad News Daily, “The highly personalized nature of the vaccines means that their development is often complicated by complex manufacturing processes. In the case of AGS-003, production requires collection of dendritic cells from the patient via leukapheresis, a blood collection process to isolate white blood cells. These cells are then transported to Argos Therapeutics’ manufacturing facility, where RNA, which is isolated from the patient sample, is used to program the dendritic cells to target the entire disease-antigen repertoire. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and transported back to the patient’s physician. It is likely that the manufacture of AGS-003 will take several days, and will have to be carried out several times over the treatment schedule for each patient. The high costs associated with this and other similar manufacturing processes are likely to limit the potential patient population for these cancer vaccines. The difficulties in achieving a clinical benefit with cancer vaccines in late-stage patients, for the reasons described above, can also complicate the development process for new cancer vaccines. In addition, traditional clinical trial endpoints were originally developed to suit standard cytotoxics, and may not suit the novel mechanism of action of cancer vaccines.”
Dr. Slowey says that she expects the failure of the Derma trial to hit GlaxoSmithKline hard. “The failure of the Derma trial will come as quite a blow for GlaxoSmithKline, as the trial was already running in a subgroup of melanoma patients (MAGE-A3 positive) that the company felt would show greatest benefit from treatment with the drug,” she told Med Ad News Daily. “MAGE-A3’s failure could also bring into question its development in other indications, such as the ongoing Phase I trial non-small cell lung cancer. Overall, MAGE-A3’s failure in melanoma will not significantly impact GlaxoSmithKline as a company, as the drug was not expected to generate significant revenue in the market. GlaxoSmithKline currently has two targeted therapies on the market for the treatment of BRAF V600-mutation positive melanoma, Tafinlar and Mekinist, which are expected to gain significant uptake over the next two years. The company is likely to have expected these drugs to generate the majority of its revenue in the melanoma market.”
Posted: September 2013