In TALAPRO-1, TALA showed antitumor activity and a manageable toxicity profile in men with mCRPC and DNA damage repair alteration in genes either directly or indirectly involved in homologous recombination repair. A secondary study objective was to evaluate patient (pt)-reported pain as measured by the Brief Pain Inventory Short Form (BPI-SF).
TALAPRO-1, a single-arm, phase 2 study, included men with mCRPC who had received 1-2 taxane-based regimens for advanced prostate cancer and whose mCRPC progressed on ≥1 novel hormonal agents (abiraterone and/or enzalutamide). Pain in pts treated with TALA was assessed via BPI-SF at baseline, every 2 weeks (wks) up to wk 9, every 4 wks through wk 25, and every 12 wks thereafter until radiographic disease progression. Longitudinal mixed-effects model analyses estimated overall change from baseline scores. Results were stratified by baseline pain status (asymptomatic/mild [BPI score 0–4], and moderate/severe [BPI score 5–10]) and reported for all pts and the BRCA1/2 and non-BRCA1/2 subsets.
A total of 83 pts were included in this analysis; 45 had asymptomatic/mild pain (BRCA1/2, n=29; non-BRCA1/2, n=16) and 38 had moderate/severe pain (BRCA1/2, n=22; non-BRCA1/2, n=16). In pts with baseline asymptomatic/mild pain, no change in worst pain, pain severity, and pain interference were observed in all patients (including the BRCA1/2 and the non-BRCA1/2 subset; Figure 1A). In pts with moderate/severe baseline pain, an improvement in pain was observed (except for pain interference in the non-BRCA1/2 subset; Figure 1B).
In this heavily pre-treated population from TALAPRO-1, TALA treatment was associated with no change in measures of pain burden in all groups of pts with asymptomatic/mild baseline pain status. In pts with moderate/severe baseline pain status, TALA treatment was associated with improved measures of pain burden, except pain interference in the non-BRCA1/2 subset which did not change. These findings, combined with the antitumor activity and tolerability of TALA, suggest a favorable benefit of TALA in this pt population.
Funding: Pfizer Inc (NCT03148795)