Shares of NovoCure Limited (NASDAQ: NVCR) plummeted 29.6% on Tuesday. The plunge came shortly after the company unveiled data regarding its revolutionary Tumor Treating Fields (TTFields) therapy for non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) annual meeting.
NovoCure’s announcement revealed that patients who received TTFields in combination with standard therapies achieved a median overall survival (OS) of 13.2 months. This outperformed those treated solely with standard therapies by 3.3 months.
The company went on to highlight the “profound OS benefit” witnessed among a subgroup of patients who also received immune checkpoint inhibitors (ICIs). Surprisingly, this subset of patients experienced a median overall survival (OS) of 18.5 months when treated with TTFields plus ICIs. This significantly surpassed the median OS of 10.8 months observed in patients treated solely with ICIs.
However, despite these seemingly positive results, NovoCure’s healthcare stock took a severe hit. Analysts were quick to point out that the number of patients treated with ICIs was relatively small, amounting to only 66 individuals. This raised concerns among industry experts, given that ICIs like Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo have become the gold standard for NSCLC treatment. The validity of NovoCure’s data and its ability to replicate such impressive survival benefits in real-world scenarios have come under scrutiny.
This response underscores the critical importance of clinical trial design. Even with favorable outcomes, if observers in the industry find flaws in the trial methodology, positive results can be quickly overshadowed by doubt and skepticism.
Nevertheless, NovoCure’s main challenge lies not in winning over analysts but in obtaining regulatory approval for TTFields in the NSCLC indication. Furthermore, the company must convince payers to cover the cost of its device. They also need to gain the trust and confidence of physicians, who play a pivotal role in prescribing TTFields to their lung cancer patients.
The current doubts surrounding NovoCure’s clinical results may prove to be obstacles in achieving these objectives. However, it is essential to note that skepticism does not automatically negate the possibility of NovoCure achieving commercial success in the NSCLC field.
Undeterred by the recent setback, NovoCure has announced plans to file for U.S. Premarket Approval for TTFields as a treatment for NSCLC later this year. In addition, the company anticipates releasing results from three other late-stage studies targeting different indications with its groundbreaking device by the end of 2024.