SD-101, a novel immunotherapy drug for low-grade lymphoma, reported promising results from a phase 1/2 clinical trial on Saturday at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida (December 5-8).
Low-grade lymphoma is a long-term illness characterized by prolonged periods of remission and recurrence. In advanced stages of the disease, physicians typically try to control lymphoma rather than cure it, as the disease is slow-growing and can present with little to no symptoms.
In a poster reporting early trial results, presenters provided data on 13 evaluable patients, none of whom had received prior treatment for their low-grade lymphoma. Primary endpoints of the phase 1/2 trial, which is ongoing, are maximum tolerated dose and safety of SD-101. Researchers are also evaluating anti-tumor activity, pharmacodynamics, and duration of response.
In the patient cohort, injections of the drug were well tolerated, with no serious adverse events reported to date. The most common side effects were fever and agitation at the site of injection, all of which resolved within 48 hours. Thus far, the maximum tolerated dose has not been identified.
Using SD-101 with low-dose radiotherapy resulted in tumor regression not only in site of injection, but also in other areas where cancer cells had metastasized, in 11 of the 13 patients. One additional patient also showed a partial response by day 180.
Although this was only an initial report of what will be a much larger study, the results are encouraging for patients with low-grade lymphoma. Researchers are confident that the treatment will continue to be successful.