Repare Therapeutics has presented updated data from its Phase I MYTHIC clinical trial, which shows the benefits of an individualised schedule for managing anaemia in patients with cancer.
The trial involved treating subjects with a combination of a first-in-class protein kinase, membrane-associated tyrosine/threonine one (PKMYT1) inhibitor, lunresertib, and camonsertib, an oral small-molecule ATR inhibitor (lunre+camo).
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It previously showed positive clinical activity with lunre+camo in molecularly selected patients across various tumour types.
The latest analysis followed patients for nearly nine months at the recommended Phase II dose to assess the individualised schedule effectiveness.
This approach mitigated mechanism-based anaemia while maintaining clinical benefit, with no observed thrombocytopenia or serious neutropenia.
Repare executive vice-president and chief medical officer Maria Koehler said: “This individualised schedule in heavily pretreated patients with advanced cancers from our MYTHIC clinical trial met its goal of maintaining antitumor activity while reducing rates of grade 3 anaemia.
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By GlobalData“We believe that these data demonstrate a favourable and differentiated tolerability profile versus both current and emerging therapies. We look forward to sharing efficacy data from the gynaecological cancer expansion cohort of the MYTHIC clinical trial in December 2024.”
The individualised schedule, based on entry haemoglobin levels, was effective in a minority of subjects who experienced mechanism-based anaemia.
Overall, clinical benefit was said to be maintained after a schedule change, with molecular responses and generally maintained radiographic regressions.
After undergoing nine weeks of therapy, no impact was observed on progression-free survival (PFS) in subjects who started on or switched to the two-week on/one-week-off treatment schedule.
Baseline marrow function was identified as the primary cause for grade 3 anaemia rather than exposure to therapy and it is observed that the dose optimisation significantly reduced grade 3 anaemia rates from 51.4% to 22.6%.
The reduction in anaemia was seen in patients with baseline haemoglobin levels less than 11g/dL, with a 58% overall risk reduction.
The new schedule also led to fewer red blood cell transfusions, dose interruptions, and dose reductions compared to the previous schedule.
Repare recently dosed the first subject in its Phase I POLAR clinical trial of RP-3467, for the treatment of various solid tumours.
