The FDA Oncologic Drugs Advisory Committee (ODAC) met yesterday and unanimously recommended that Avastin offered benefit to patients with previously untreated Glioblastoma multiforme (GBM), a fatal form of brain cancer. If accelerated approval is granted on May 5th, it will be the first new treatment for the disease in 10 years.
The American Cancer Society estimates that 21,810 malignant
tumors of the brain or spinal cord are diagnosed per year in the United States; approximately 10,000 of these are likely to be Glioblastoma. GBM has a tendency to recur and relapse is common. There are few non-surgical options available to patients, so it represents an area of high unmet medical need.
What was so compelling about the Avastin data?
According to Genentech, the non-comparative Phase II data from the BRAIN study involved 167 patients, of who 85 received treatment with Avastin in combination with irinotecan and were compared to Avastin alone in patients who had previously progressed on prior temozolomide and radiotherapy. Primary endpoints included objective response rate and progression free survival (PFS). Secondary endpoints included OS and safety.
- In 28 percent, tumors shrank to at least half their original size;
- In those whose tumors shrank, half experienced a response of at least 5.6 months;
- 43 percent lived six months without their disease getting worse; and
- Half lived at least 9.3 months after starting treatment with Avastin and 38 percent survived longer than one year."
There were no new adverse events beyond those reported in previous indications for colorectal, lung and breast cancer.
There are few available treatments for patients who have relapsed after treatment with temozolomide (Temodar). Temozolomide is approved for the first line treatment of GBM and showed significant survival of 2.5 months when used in combination with radiotherapy (RT) compared to RT alone. It makes approx. $1B in revenues annually. I'll be curious to see how the phase III frontline trial shapes out, what the comparator arm will be and how well patients do on upfront Avastin. If the phase II refractory data is anything to go by, the results may look fairly promising.