October 12, 2016
By Mark Terry, BioSpace.com Breaking News Staff
At last weekend’s European Society for Medical Oncology (ESMO) meeting, a number of companies presented data from clinical trials. Cory Renauer, writing for The Motley Fool, takes a look at three smaller companies that presented interesting data worth considering.
First up, Celldex Therapeutics presented data from its glembatumumab vedotin, dubbed glemba, to treat advanced skin cancer. In what at first glance seems like setting a low bar, the company was hoping the drug would show responses in at least six of the first 52 patients being treated with glemba. In fact, there were seven positive responses out of 62.
Renauer writes, “On the surface, the results aren’t thrilling, but it’s important to understand the severity of the patients involved. All of those enrolled had progressed following, or during, treatment with one or more checkpoint inhibitors—groundbreaking new therapies that disable a cloaking device cancer cells use to hide from the immune system—and had few options remaining. In fact, the majority of patients had received at least three prior lines of therapy, and all but one patient was in stage four of the disease.”
As a result, Celldex has added a second patient group to the trial, which will receive a combination of glemba and varlilumab, another Celldex drug. Varlilumab stimulates the immune system differently than the other drugs the patients have received.
The second company is Exelixis . It recently announced results from its CABOSUN Phase II trial of cabozantinib in previously treated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease. Cabozantinib was compared to patients receiving Pfizer ’s Sutent (sunitinib). The median progression-free survival (PFS) for cabozantinib (Cabometyx) was 8.2 months. The PFS for patients on sunitinib was 5.6 months. The results demonstrated a 31 percent decrease in disease progression or death in patients on cabometyx compared to patients on Sutent.
So far, Cabometyx is approved only in patients who have previously received therapy. Sutent, on the other hand, is approved as a first-line treatment. It is also approved in the U.S. to treat gastrointestinal stromal tumors and pancreatic neuroendocrine tumors. As a result, Exelixis is planning to submit to the U.S. Food and Drug Administration (FDA) a Supplemental New Drug Application (sNDA) for cabozantinib to treat first-line advanced renal cell carcinoma.
And third is Tesaro . Tesaro is working with a new class of cancer drugs, PARP inhibitors (PARPi). The only PARPi on the market currently is AstraZeneca ’s Lynparza for BRCA-positive advanced ovarian cancer. There are others being investigated, including Tesaro’s niraparib, AbbVie ’s veliparib, Clovis Oncology ’s rucaparib, and Medivation ’s (now Pfizer)’s talazoparib.
In its Phase III trial, Tesaro’s niraparib met its endpoints of progress-free survival (PFS) in patients with ovarian cancer. It expects to file for approval with the FDA by the end of the year, with a final decision in 2017.
Renauer writes, “At this pace, it looks like Tesaro might be able to see niraparib reach pharmacy shelves before it needs to raise more capital. The FDA granted the candidate fast-track status, and Tesaro began submitting data for niraparib’s application in September. Tesaro stock has already gained about 128 percent this year, inflating its market cap to about $6.1 billion at recent prices. A speedy approval of niraparib for all recurrent ovarian cancer patients could send it even higher.”
