Hay una necesidad médica importante no satisfecha en SCLC ... Donde las opciones muy limitadas.
La última aprobación de la FDA oara SCLC data de 1996.
PharmaMar announced that the 600-patient ATLANTIS trial of Zepsyre in relapsed SCLC patients is around 75% enrolled, with enrolment expected to complete in June/July. With this timing in mind, top-line data are expected around H119. As a reminder, in previous data at the same dose being used in ATLANTIS, Zepsyre demonstrated PFS of 5.3 months, which is higher than the three to four months typically seen with Topotecan, the current standard of care.
There is a significant unmet medical need in SCLC and there are very limited options, with the last FDA approval coming in 1996. It is an extremely aggressive disease with median survival from diagnosis at only two to four months without treatment. Also, even those who do get treated usually relapse. Overall survival at five years is only 5-10%, according to the National Cancer Institute. Around 80,000 patients are diagnosed with the cancer every year in the US and Europe.
Beyond SCLC, PharmaMar is also about to embark on a 500-patient Phase III trial in second-line endometrial cancer. Zepsyre had previously demonstrated a 44% response rate and median progression-free survival (PFS) of 7.8 months in this patient population, which is noteworthy as these patients are typically chemo-resistant with PFS closer to 3.2 months. We expect the Phase III to be initiated around the middle of this year.
We are decreasing our valuation to €1.12bn or €5.04/share from €1.35bn or €6.06/share as we have removed Zepsyre in breast cancer from our model following company comments on its earnings call regarding de-emphasis of the programme due to a shifting treatment paradigm. We have also lowered our estimates for Yondelis due to continued pricing pressure. This was partly mitigated by rolling forward our NPVs.