Morgan Stanley Awaits This Merck Data

In a report published Tuesday, Morgan Stanley analysts maintained an Equal-Weight rating on

, saying that the company is filing in select patients in lung cancer earlier than expected, but its best to wait for survival data. "Merck submitted Keytruda for approval in previously treated high-expressing PD-L1 lung cancer (≥50% of tumor cells PD-L1+) patients based upon select data from KEYNOTE-001. In these patients, median PFS was 6.1 months and ORR was 43.9%, compared to two months median PFS and 10-15% ORR for low expressing or PD-L1- patients," the analysts wrote. "However, overall survival (OS) data is not yet available and the study has no control arm. The FDA has 60 days to accept the filing, so we should know by mid-June. However, Merck's actual filing date was not disclosed, so the FDA may make a filing acceptance decision much sooner," the analysts said. In the report Morgan Stanley noted, "If the FDA accepts the filing, the PDUFA date assuming Priority Review would be in mid-December (eight months from filing date so could be earlier). Merck will be generating additional data in lung cancer this year, which FDA may need to see before issuing approval." In case the FDA accepts the filing, will the regulatory body wait for OS data? The analysts believe that the FDA will wait, so "hopefully Merck's survival study (KEYNOTE-010) will be stopped early at an interim look this year."