Early durability data lift Turning Point, but market size questions loom

Proving that repotrectinib can generate durable responses has always been one of Turning Point’s biggest hurdles, and an update yesterday on Ros1-positive NSCLC cohorts from the Trident-1 trial suggests that the project has a shot at succeeding. 85% of patients who received repotrectinib as a first-line therapy were still responding at 12 months, beating Stifel analysts’ 70% “bull case” and coming in substantially higher than Roche's Ros1 agent Rozlytrek. That asset, which already has a first-line label, boasts 12-month duration of response of around 60%, and to compete Turning Point needs incontrovertibly better data – at least 19 months, Stifel analysts believe, adding that while repotrectinib's results are trending in the right direction they are not yet mature. ORR was also updated, showing the first-line cohort deteriorating from previous updates, albeit remaining impressive; in arms evaluating TKI-failed patients, where the market is wide open, ORR is just about holding up. Turning Point now needs to persuade regulators that the data are good enough for accelerated approval and a line-agnostic label. Convincing investors that this is a market worth fighting for could present the final challenge: Rozlytrek sales have plateaued at $15m for the last three quarters.

Turning Point's Trident-1 study – Ros1+ cohorts
Cohort EXP-1 (n=55) EXP-2 (n=60) EXP-3 (n=40)* EXP-4 (n=60)
Treatment line Naive 1 TKI + 1 prior chemo 2 TKIs, no prior chemo 1 TKI, no prior chemo
Previously reported ORR  91% (n=22) 50% (n=12)  0% (n=10) 67% all PRs (n=9)
ORR at Triple meeting 2021 Not updated 39% (n=23)  30% (n=10)  38% (n=39)
ORR April 2022 79% (n=71) 42% (n=26)  28% (n=18)  36% (n=56)
Note: Ros1+ cohorts are NSCLC; *before modification this cohort allowed prior chemo; Rozlytrek approved first line on 67% ORR; Xalkori approved first line on 66% ORR; Lorbrena used off-label second line on 35% ORR (has CNS tox). Source: company presentations.

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