The AERN study is a phase II trial which is investigator sponsored and conducted in many European
trial sites. It is enrolling patients with relapsed or refractory Hodgkin lymphoma who progressed on
anti-PD-1 treatment. These are patients who usually don’t have any novel treatment options left or
approved and it’s an unmet need which we try to address.
In the trial they’re receiving the anti-PD-1 antibody nivolumab which is then combined with 20Gy of
radiotherapy to one single lesion and we aim to induce a systemic immune response leading to an
abscopal effect. The abscopal effect, basically, means that due to the radiotherapy and the priming of
the immune system we have also regression of distant sites which are not within the radiation field.
This trial is conducted in a two-stage design so in the first stage we enrolled nine patients and now
conducted the interim analysis and the DMC recommended to make this data public. The data are
very encouraging because overall the treatment was feasible, it was well tolerable, so the majority of
the toxicities were of grade 1 and only a few grade 2 and a single grade 3 toxicity was observed.
Overall the treatment was effective because we observed partial remissions in more than half of the
patients, so five out of nine responded with a partial remission leading to an objective response rate of
56%. The abscopal response rate, which is even more interesting, also is at 56%. So more than half
of these patients actually responded outside of the radiation field which makes this a very promising
treatment option. The trial is continuing enrolment for stage 2 with an additional 20 patients.
The progression free survival currently, with a median observation time of 15 months, is at 42%, so
rather encouraging also for this heavily pre-treated patient population.