What happened
Shares of NovoCure (NVCR -0.89%) were crashing 29.6% lower as of 10:19 a.m. ET on Tuesday. The steep decline came after the company announced data for its Tumor Treating Fields (TTFields) therapy in treating non-small cell lung cancer (NSCLC) that it's presenting today at the American Society of Clinical Oncology (ASCO) annual meeting.
NovoCure reported that patients receiving TTFields combined with standard therapies achieved median overall survival (OS) of 13.2 months, compared to 9.9 months for patients treated only with standard therapies. The company said that there was a "profound OS benefit" with a subgroup of patients who received immune checkpoint inhibitors (ICIs). Patients in this subgroup who received TTFields plus ICIs had a median OS of 18.5 months, compared to a median OS of 10.8 months for patients treated only with ICIs.
With this seemingly positive news, why did the healthcare stock plunge? Some analysts noted that only a few patients (66) were treated with ICIs. However, ICIs such as Merck's Keytruda and Bristol-Myers Squibb's Opdivo are now the standard of care for NSCLC. There are concerns about whether NovoCure's data really reflects the likelihood of an impressive survival benefit for TTFields in the real world.
So what
The response to NovoCure's latest data underscores the importance of clinical trial design. Even positive results can be disappointing if industry observers find fault with how the trial was done.
NovoCure's real challenge isn't convincing analysts, though. The company must first win regulatory approval for TTFields in the NSCLC indication. It then needs to persuade payers to cover its device. Finally, NovoCure must gain the confidence of physicians so that they prescribe TTFields to their lung cancer patients.
Skepticism about its clinical results could especially make the latter two objectives more difficult. However, that doesn't necessarily mean that NovoCure won't be able to achieve commercial success in the NSCLC indication.
Now what
NovoCure now plans to file for U.S. Premarket Approval for TTFields in treating NSCLC later this year. The company also expects to announce results from three other late-stage studies of its device targeting other indications by the end of 2024.
