Top-line data from the phase I/IIa trial with TG01 in combination with Gemcitabine (Gem) showed a 2-year overall survival (OS) rate of 72% in 32 patients with resected pancreatic cancer. This is a significant improvement compared with previously reported interim data (68% in 19 patients) and historical survival rates (c30–53%) from other studies. Overall, we think the data puts Targovax in a good position leading up to the planned pivotal phase II trial. We reiterate our BUY recommendation and NOK31 target price.
Top-line data even better than previous interim data. On May 24, Targovax released top-line data showing a 2-year OS rate for the full TG01 trial in resected pancreatic cancer. The new data is from the second cohort of patients, who received a slightly modified dosing schedule. Cohort 2 included 13 patients who received injections before and after, but not during, chemotherapy treatment, while patients in cohort 1 also received injections during chemotherapy treatment. We saw in a previous interim readout that cohort 1 had a 2-year OS rate of 68%. The previous interim data was encouraging compared to historical reported OS rates of c30–53% after 2 years in resected pancreatic cancer patients; however, we remained cautiously optimistic given the results were based on just 19 patients. The latest data showed that the second cohort had a 2-year OS rate of 77%. In essence, we believe this data is strong not only since it demonstrated an increased OS in the combined OS shown in more patients, but also since patients in the second cohort received fewer injections. Adding the two cohorts together would give a total 2-year OS for all 32 patients of 72%.
New data indicates superior efficacy over monotherapy with Gemcitabine. The company also reported that the median overall survival (mOS) for all 32 patients was 33.4 months. This data is attractive compared with treatment with Gem alone. Comparing this data with the most recent, large trial on resected pancreatic patients only treated with Gem (the ESPAC4 trial) shows the mOS in these patients was 27.6 months, i.e. in the TG01 trial the company showed a c6-month longer mOS rate.
BUY recommendation and NOK31 target price reiterated. We believe the data is a positive catalysts for the shares, and is stronger than expected. With this in mind, we reiterate our BUY recommendation and NOK31 target price.
Dagens tekst fra DNB