The National Comprehensive Cancer Network, NCCN, is the health body which sets the world guidelines in treating cancer. The NCCN recommends clinical trials as the preferred option over current standard protocols for pancreatic cancer patients in good shape as these patients can gain from treatments at the forefront of science far more than the standard of care unsatisfactory treatments.
The problem in advanced stages of pancreatic cancer treatment
Response is very rare after two lines of treatments in pancreatic cancer and is close to zero. The common treatment leads to between 2 and 3 months survival. Patients in this advanced stage where they have failed two previous treatment lines are in desperate need of effective therapies. There are no FDA-approved treatments for third-line pancreatic cancer and no guideline recommendations other than participating in clinical trials and here is another example for the reason for the NCCN recommendation.
About TYME-88-Panc study
This was a phase II study, multicenter where all patients received the innovative cancer drug. Investigators evaluated SM-88 in patients with pancreatic ductal adenocarcinoma who received ≥1 prior line of therapy.
SM-88 is a novel oral anticancer drug that attacks metabolism. This is one of the first agents in this class of new compounds, which is a new wave of treating cancer.
The investigational oral drug SM-88 demonstrated promising survival in a phase II study called “TYME-88-Panc study” in patients with advanced pancreatic cancer. The median survival seen was 6.4 months. The survival is very encouraging, 6.4 months, in a population where the standard-of-care treatment leads to between 2 and 3 months.
Interestingly, an analysis showed that females had improved survival outcomes with SM-88.
44% of patients achieved stable disease or better, and there was a 92% reduction in the risk of death among patients who reached at least stable disease. Also, the response to SM-88 was durable, as the majority of patients who received SM-88 continued to respond over 7 months.
Regarding safety of SM-88
Serious adverse events that were potentially treatment-related were reported in 4% of the patients in the study, and included abdominal pain, arthralgia, and hypotension. 94% of patients experienced some kind of adverse event possibly related to treatment.
The study shows a few very interesting things. On one end, the drug is oral, which is always an advantage. Second, it is very well tolerated, very safe, which is of utmost importance in a fragile patient population.
Following discussions with the FDA, SM-88 will now be explored in a phase II/III clinical trial in which patients with metastatic adenocarcinoma of the pancreas whose disease has progressed or reoccurred will be randomized to receive SM-88 or physician’s choice of therapy. Patients must have received 2 prior lines of therapy.
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