I had the privilege to present the data on behalf of my co-authors about the combination strategy of mosunetuzumab sub-Q plus lenalidomide induction followed by maintenance. So the study was designed for patients with first-line follicular lymphoma presenting with high tumor burden criteria, so according to the GELF criteria. So the patients were treated in two phases...
I had the privilege to present the data on behalf of my co-authors about the combination strategy of mosunetuzumab sub-Q plus lenalidomide induction followed by maintenance. So the study was designed for patients with first-line follicular lymphoma presenting with high tumor burden criteria, so according to the GELF criteria. So the patients were treated in two phases. The first one was an induction phase of one year and a potential maintenance of 18 months. So the Mosunetuzumab was administered sub-Q with the first cycles of three weeks just for the step of dosing and then 11 cycles with an infusion every four weeks. The lenalidomide was added orally from cycle 2 to cycle 12 at the common dose in lymphoma of 20 milligrams per day from day 1 to day 21. And at the end of this induction phase, a patient who reached at least a partial response could enter the maintenance phase with only mosunetuzumab sub-q every eight weeks for nine cycles. It was at the discretion of the investigator. So 43 patients entered the induction phase and 16 the maintenance phase per the physician decision.
So the results are really impressive in terms of efficacy. The overall response rate is 90% and the complete response rate is 87%, so very high rates of complete response. Those responses are durable, either the response or the complete response, with more than 90% of response at two years, both for overall response and complete response. And the PFS and the overall survival are also very good with only one patient dying throughout the study. So very impressive results in terms of efficacy and very good safety profile. Nothing unexpected, I would say. The toxicities are those from both products, both the bispecific antibodies and the lenalidomide, so we know the toxicity of each product. We’ve seen some CRS, as expected I would say, with mosunetuzumab, but only low grade, only grade 1-2, no grade 3-4, and only two patients out of 43 at grade 2, so a very safe profile. There was no CRS during the maintenance phase, there was no ICANS, so no neurotoxicity at all for all the patients, whatever the phase, either the induction phase or the maintenance phase, and low rate of infection, grade 3/4 infection, both during the induction and the maintenance phase. So overall, a very good safety profile and a very encouraging efficacy profile as well. So the future of this combination strategy is currently the phase three MorningLyte trial investigating this exact same combination strategy with induction and maintenance as compared with the usual immunochemotherapy regimen with G-CHOP, G-Bendamustine, R-CHOP or R-Bendamustine, followed by the anti-CD20 maintenance strategy. So we will have the results in a few years, hopefully.
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