Moderna shares steady after ESMO data leak crash

Moderna’s share price is steadying after leaked phase 3 data for its personalised melanoma vaccine, developed with Merck, sent shares tumbling last week.

Shares closed 17.3% lower at $202.63 on Thursday 22 October, when the data emerged, having fallen as much as 26% during the day. They lost a further 1.3% on Friday.

On Monday, shares dropped by as much as 9% in pre-market trading before recovering most of those losses to close down 0.6% at $198.85.

What happened?

The sell-off followed a rally that had lifted Moderna’s share price more than fivefold this year, fuelled by phase 2b results and an August announcement that the phase 3 trial had met its primary endpoint.

Although INTerpath-001 met its primary endpoint, the full results may not have lived up to investor expectations. The trial found that intismeran autogene plus Keytruda (pembrolizumab) reduced the risk of recurrence or death by 42% compared with Keytruda alone.

This was less than the 49% reduction reported in the earlier phase 2b KEYNOTE-942 study. However, differences in trial size and follow-up mean the results are not directly comparable.

The unplanned disclosure may also have added to market uncertainty, as investors assessed the findings ahead of the scheduled presentation.

Despite the more modest benefit, Dean Li, President, Merck Research Laboratories, described the findings as “one of the most significant advances in melanoma treatment since the advent of immunotherapy”.

ESMO investigates data leak

The INTerpath-001 results were due to be presented at the European Society for Medical Oncology (ESMO) Presidential Symposium in Madrid on Saturday 24 October.

However, a leak first reported by STAT prompted ESMO to lift the embargo, allowing Merck and Moderna to release the full results two days early. ESMO has said it is investigating the breach.

Regulatory plans and wider pipeline

With the phase 3 results now public, Merck and Moderna plan to engage with regulatory authorities on potential submissions for the combination.

Their development programme also extends beyond melanoma. The INTerpath programme includes nine phase 2 and phase 3 trials of intismeran across non-small cell lung cancer, bladder cancer and renal cell carcinoma.

These include a phase 3 trial in high-risk stage I non-small cell lung cancer, testing the vaccine both alone and in combination with Keytruda.

Moderna is due to report its third-quarter financial results and provide a company update on 6 November, when investors will be looking for further insight into its outlook for its oncology partnership with Merck.