Shares of Summit Therapeutics SMMT surged 56% on Monday after it reported additional results from the phase III HARMONi-2 study, which compared its investigational antibody ivonescimab (SMT112) with Merck’s MRK blockbuster drug Keytruda (pembrolizumab) in certain patients with non-small cell lung cancer (NSCLC).
Data from the study showed that the drug reduced the risk of disease progression or death by nearly half when compared to Keytruda. This data conforms with the initial results reported by SMMT in May wherein treatment with ivonescimab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS).
The HARMONi-2 study evaluated ivonescimab against Merck’s Keytruda in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.
SMMT Boasts Ivonescimab Efficacy Over Keytruda
Patients who received the SMMT therapy achieved a median PFS of 11.14 months compared to 5.82 months for those receiving the MRK drug. This difference showed that ivonescimab cut the risk of disease progression or death by 49% compared with Keytruda.
A clinically meaningful benefit of the drug was also seen across multiple clinical subgroups, including those with PD-L1 low and high expression, squamous and non-squamous histologies, and other high-risk patients.
Both the overall response rate (ORR) and the disease control rate (DCR) were also higher in patients treated with ivonescimab than those treated with Keytruda. Treatment with the drug achieved an ORR of 50% compared with 38.5% for those receiving Merck’s drug. The DCR for ivonescimab-receiving patients stood at 89.9% compared with 70.5% for Keytruda.
Unlike Keytruda, which targets the PD-1 protein, the Summit drug is a first-in-class bispecific antibody that targets two proteins, namely PD-1 and VEGF. Management believes that this dual mechanism differentiates ivonescimab from currently available therapies for solid tumors as there is a potentially higher expression of both PD-1 and VEGF in tumor tissue compared to the normal tissues in the body.
SMMT Stock Performance
Following the results announcement, shares of Summit hit an all-time high price of $21.50. Per SMMT, ivonescimab is the first drug to achieve a statistically significant improvement compared to Merck’s Keytruda in a head-to-head set-up in a late-stage study in NSCLC indication. Keytruda is also the standard of care in NSCLC indication.
Some investors pointed out that the results indicate that ivonescimab could replace Keytruda as the next standard of care across multiple NSCLC settings. This major factor was not only responsible for Summit’s share price soaring but also sent Merck’s stock down 2% after the results were announced.
Year to date, Summit’s shares have skyrocketed more than 600% against the industry’s 3.4% decline.
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Summit’s Future Plans for Ivonescimab
The HARMONi-2 study was conducted in China by the company’s partner Akeso, which is also the original developer of the drug. Summit acquired an exclusive license from Akeso in 2022 to develop and market ivonescimab in the United States, Canada, Europe and Japan. The company expanded its licensing deal this June, which now also covers Latin America (including Mexico and all countries in Central America, South America and the Caribbean), the Middle East and Africa.
Based on HARMONi-2 results, SMMT announced plans to start the phase III HARMONi-7 study early next year, which will compare ivonescimab with Keytruda in patients with metastatic NSCLC whose tumors have high PD-L1 expression. Based on details at a government website, data from this study is expected in 2027.
Summit is presently conducting two late-stage studies, namely HARMONi and HARMONi-3 studies, evaluating ivonescimab in separate settings for NSCLC indication.
Currently, ivonescimab is only approved in China to treat patients with EGFR mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR-TKI. This approval, which was received in May 2024, is based on data from the late-stage HARMONi-A study, which showed that treatment with the drug achieved the primary endpoint of PFS when compared to placebo.
Our Take
Despite the encouraging study results, Summit still has a long way to go. As the HARMONi-2 study was conducted solely in China, the FDA is unlikely to accept the study results given the lack of a diverse patient population – a likely reason for management to conduct the HARMONi-7 study across several countries.
As ivonescimab is yet to be approved by the FDA, Keytruda sales are unlikely to be affected, at least for the next couple of years until SMMT secures the drug’s approval. Merck stock faces the looming threat of loss of Keytruda’s exclusivity post-2028.
SMMT’s Zacks Rank
Summit currently carries a Zacks Rank #3 (Hold).
Summit Therapeutics PLC Price
Summit Therapeutics PLC price | Summit Therapeutics PLC Quote
Our Key Picks Among Biotech Stocks
A couple of better-ranked stocks in the overall healthcare sector are Bioventus BVS and Fulcrum Therapeutics FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 EPS have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 99.2%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 loss per share have improved from $1.71 to $1.51 during the same period. Year to date, Fulcrum Therapeutics’ shares have soared 27.9%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum Therapeutics delivered a four-quarter average earnings surprise of 393.18%.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>Merck & Co., Inc. (MRK) : Free Stock Analysis Report
Summit Therapeutics PLC (SMMT) : Free Stock Analysis Report
Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
Bioventus Inc. (BVS) : Free Stock Analysis Report
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