Summit Therapeutics: Is Their Lung Cancer Drug a Game Changer? Summit Therapeutics Inc. aims to advance Ivonescimab, a potential breakthrough for NSCLC. The FDA's Fast Track designation boosts its U.S. clinical pathway.

Summit Therapeutics Inc. (NASDAQ: SMMT) is a development-stage biotech company specializing in novel therapies for oncology and infectious diseases. Their leading drug candidate is Ivonescimab, an immunotherapy treatment being tested on non-small cell lung cancer (NSCLC). The stock is trading up 627% year-to-date (YTD) on the belief that it could be a game-changer in the fight against advanced lung cancer. Its stunning Phase 3 clinical trial results shocked the medical sector. Analysts believe it has the potential to be more effective than Merck & Co.'s (NYSE: MRK) blockbuster drug Keytruda (pembrolizumab) against NSCLC.

Keytruda is the blockbuster drug that's considered the most effective solid tumor therapy currently on the market, generating over $25 billion in sales in 2023.

Phase 3 Clinical Trials Were Performed in China

It's important to note that Chinese drug developer Akeso actually developed the drug, which is also known as AK104. Summit Therapeutics obtained the license to commercialize Ivonescimab in the United States for various cancers. Akeso conducted the HARMONi-2 Phase 3 trials testing Ivonescimab directly against Keytruda using 398 patients in China. Patients were randomly given intravenous Ivonescimab or Keytruda shots over two years.

HARMONi-2 Study Results in Crush Keytruda, a Game Changer

Ivonescimab met its primary endpoint of progression-free survival (PFS) as a first-line therapy. Secondary endpoints included overall survival (OS), duration of response (DOR), and objective response rate (ORR). Ivonescimab is a bispecific antibody that binds simultaneously to two different targets, the PD-1 receptor to boost the immune response and vascular endothelial growth factor (VEGF) to inhibit blood vessel growth in the tumor.

The resulting PFS reduced the risk of disease progression or death by 49% in first-line PD-L1 positive advanced NSCLC compared to Keytruda. Ivonescimab patients achieved a PFS of 11.4 months compared to 5.82 months for Keytruda. It also outperformed in ORR and DCR. It was the first drug to improve over the incumbent Keytruda materially. The news sent shares rocketing up from $12.93 to $33.89 in five days upon gapping on Sept. 9, 2024.

FDA Grants Fast Track Designation

On Oct. 4, 2024, the FDA granted a Fast Track designation for Ivonescimab for the treatment of advanced lung cancer in combination with platinum-based chemotherapy. However, the FDA doesn't give much credit to data from Chinese clinical trials. Summit Therapeutics will likely have to perform Phase 3 clinical trials in the United States. Additional Phase 3 studies could also include HARMONi-7, which would be used to treat first-line PD-L1 high advanced NSCLC patients. From there, it could be expanded to target other types of cancer, including liver, breast, head, and neck.

Each Phase 3 clinical trial positive result could build up more momentum for the stock. Summit Therapeutics is looking at another two to three years of clinical trials. Meanwhile, the company has $325.8 million in cash with a quarterly burn rate of around $45.6 million, which gives it a runway until the end of 2025, when it will need to raise more capital before then. Summit Therapeutics is undergoing two multi-regional Phase 3 studies, which are HARMONi and HARMONi-3 and HARMONi-7, to start in early 2025. HARMONi top-line results are expected in mid-2025.

SMMT Stock Forming a Symmetrical Triangle Breakdown

A symmetrical triangle is comprised of a descending upper trendline resistance converging with an ascending lower trendline support at the apex point. A breakdown occurs if the stock collapses below the lower trendline support.

SMMT peaked at the $33.89 swing high to commence the descending upper trendline resistance, meeting the ascending lower trendline support at the apex point. SMMT stock fell under the lower trendline and below the daily anchored VWAP at $19.77. The daily RSI is flat at the 45-band. Fibonacci (Fib) pullback support levels are at $15.95, $12.93, $11.75, and $9.95.

SMMT's average consensus price target is $35.57, implying an 87.8% upside and its highest analyst price target is $44.00. It has two analysts' Buy ratings and one Hold rating. The stock has a 2.1% short interest.