To say this has been a big year for Summit Therapeutics (NASDAQ: SMMT) would be a huge understatement. The stock has risen over 600% since the end of 2023, thanks to surprisingly positive trial results for a cancer therapy called ivonescimab.
The stock market has been pushing up Summit's stock price because there's a chance that ivonescimab could unseat Merck's Keytruda as the world's top-selling cancer treatment. Keytruda racked up a stunning $25 billion in sales last year, so there's a lot to be gained if Summit's candidate continues to succeed.
Summit Therapeutics is on the right path, but it could be too early to predict buckets of incoming revenue. Its candidate isn't even approved in the territories where Summit intends to sell it.
Despite having no products to sell, Summit's market cap shot above $23 billion in September after investors saw interim results of the Harmoni-2 trial. The study assembled hundreds of newly diagnosed lung cancer patients in China and treated them with either Keytruda or ivonescimab. Measurements taken at a planned interim checkup showed patients randomized to receive ivonescimab were 49% less likely to show signs of disease worsening.
Human immune cells come with programmed death (PD-1) receptors as a safety feature that shuts down attacks when they spill over and affect healthy tissues. Tumor cells exploit this checkpoint to evade immune attacks before they begin. Keytruda, Opdivo, and Tencentriq are all blockbuster drugs that shrink tumors by inhibiting the PD-1 checkpoint.
Ivonescimab is an interesting new double-sided protein that inhibits the PD-1 checkpoint, plus it blocks vascular endothelial growth factor (VEGF) from increasing a tumor's blood supply. Summit's stock price has soared because investors think it can become the new standard of care for first-line lung cancer patients.
Lung cancer isn't the most common malignancy but claims the most lives. For cancer therapy developers, first-line indications are precious because these patients tend to stay on therapy much longer than folks who have already relapsed.
In May, ivonescimab became the first PD-1/VEGF bispecific antibody to earn approval when Chinese regulators approved it to treat a genetically defined group of lung cancer patients. Summit licensed rights to its lead candidate from a Chinese company named Akeso. Unfortunately, the U.S. Food and Drug Administration (FDA) will not approve new cancer therapies without successful results from a trial with plenty of North American volunteers.