Updated LYMRIT-37-01 data
The company updated the LYMRIT-37-01 data at ASH 2018. The trial is now fully recruited and the majority of patients have been followed-up. The data is still evolving, but the efficacy trends seem to have stabilised at a high and impressive level, in our view. ORR for the core indication 3L FL was 70% and with a CR rate of 32%. Overall median DoR was 9.0 months, which was lower than we anticipated and lower than in the abstract from early November (13.3 months).
Update on LYMRIT-37-01 trial – strong efficacy in core indication . The company updated the phase I/II trial LYMRIT 37-01 at ASH 2018. The efficacy data was very strong, with ORR consistently above 60% in all subgroups, with a CR rate between 19% and 32% in the subgroups. We find it very promising that the ORR and CR rates in 3L FL (the company’s key indication) were 70% and 32%, respectively. In our view, this is very strong efficacy data and clearly among the strongest data seen for this indication. As a comparison, copanlisib, which was recently approved by the FDA for 3L FL, in a similar setting, had an ORR of 59% and a CR of 14%.
Safety and tolerability continues to be very strong . As we have seen in the past, the safety profile for Betalutin was very strong, with the majority of the side effects stemming from the Lu177 radioisotope. As such, the side effects were primarily haematological, and peaked after c5–6 weeks and diminished thereafter (as the radioisotope half-life is c7 days). In our view, the quality of life for the patients should, given the side-effect profile, be significantly better than for most of the competing products and products under development. As Betalutin is a one-time treatment, the side-effect profile over time is also fundamentally different from a drug taken on a regular basis.
Overall median Duration of Response (mDoR) shorter than expected . In the poster, the company stated that the mDoR for the full group was 9.0 months and for the patients that reached a CR the mDoR was 20.7 months. The 9.0 months mDoR was shorter than the 13.3 months mentioned in the abstract, which we find slightly worrisome as the mDoR has declined over time in the company’s reporting. However, we understand that the mDoR has been affected by one single patient and as the trial and follow-up is ongoing, the mDoR should rebound over time. We did not receive the mDoR for 3L FL, which we find disappointing as this would be the initial indication.
We believe a positive share price reaction is warranted after the data .
