As the most common type of cancer, breast cancer is expected to be diagnosed 284,200 times in the U.S. alone in 2022. There are many ways that breast cancer can be classified in terms of stage, type, and subtype based on the characteristics and the spread of the tumor. Despite the fast-paced innovations over the past decade, there are still many unmet needs and challenges in this patient population. To name a few, there needs to be improved measures to stop the cancer from coming back. Also, some patients do not do well despite administering all the available effective treatments. In addition, for patients that do not need very aggressive therapy, it is important to determine the very few medications that their bodies need since the response is specific to the patient. For some patient subgroups, chemotherapy is their only option, which not only kills cancer cells but also healthy cells.
At a CAGR (Compound Annual Growth Rate) of 10.2%, the global market for breast cancer treatment is expected to grow from $17.87 billion in 2018 to $38.57 billion in 2026. Below are three pipeline medications that could make a significant contribution to this growth.
1. Amcenestrant by Sanofi ($SNY)
Amcenestrant is an oral SERD (selective estrogen receptor degrader). Right now, there is one FDA approved SERD available called fulvestrant, but there are clinical limitations due to its low bioavailability. It is given as an injection into the buttock muscle by a healthcare professional every 2 weeks or every month. An oral medication would be ideal, but so that’s when amnecestrant would come in. But to give an idea of how much profit a medication in this drug class can make, Faslodex (fulvestrant) generated over $1 billion in 2018 globally, with $537 million of it in the U.S.
In its phase 1 (AMEERA-1) trial, amcenestrant was combined with Pfizer’s breast cancer medication (Ibrance) to treat ER+/HER2- metastatic breast cancer patients. ER+ means that the patients had estrogen receptors on their cancer cells and so they grow in response to estrogen. 85% of breast cancer patients are ER+. On the other hand, HER2 is a protein that leads to rapid cancer cell growth if there is too much of this protein, which accounts for 20% of breast cancer. So HER2- patients have normal levels of HER2; therefore their cancer grows more slowly than HER2+ patients.
Because this drug targets metastatic breast cancer patients, it fulfills a huge clinical unmet need because there are not many treatment options available for metastatic breast cancer. Metastatic means that the cancer has already spread from the breast to other parts of the body, such as the brain, lungs, or bones.
The phase 3 trial is currently ongoing for amcenestrant, but so far, it has shown very promising results. In its phase 1 trial, it demonstrated 34% objective response rate (ORR) and 74% clinical benefit rate (CBR). The ORR refers to their percent of people who responded to the treatment, whether the response was partial or complete, per RECIST (Response Evaluation Criteria in Solid Tumors). In addition, the CBR refers to the percentage of patients that experienced any benefit from the therapy. There were also no significant side effects from this therapy.
2. Pelareorep by Oncolytics Biotech ($ONCY)
The scientific technology of pelareorep is what stands out the most. It is an oncolytic double-stranded RNA virus, so when it is injected into normal cells, it cannot replicate. The virus is just cleared by the body. However, when it enters cancer cells, pelareorep can replicate and the cancer cells burst and release contents that infect and therefore kill other neighboring cancer cells. It activates the immune system to fight off just the cancer cells, without affecting normal healthy cells.
Metastatic triple negative breast cancer (TNBC) is one of the most challenging subtypes of breast cancer to treat. TNBC refers to when there are no common breast cancer receptors (estrogen, progesterone, HER2) on the cancer cells. Therefore, triple negative breast cancer is much harder to treat because a lot of breast cancer medications target these common receptors. But if the patient does not have any of these receptors, these medications will not work, leaving chemotherapy as their only option. That is when pelareorep would come to the rescue if it gets approved, as it is being studied to be used in metastatic triple negative breast cancer in its phase 2 IRENE trial. However, it is also being studied in other clinical trials for multiple GI cancers, pancreatic cancer, and multiple myeloma. Each of these indications could be worth $1 billion or more. For a tiny company like oncolytics, the potential is vast.
3. Disitamab vedotin by Seagen ($SGEN)
Disitamab vedotin is a novel HER2-targeted antibody-drug conjugate (ADC) therapy. ADCs are a type of cancer treatment designed to specifically target and directly deliver the anti-cancer toxic agent into HER2-expressing tumor cells without harming healthy cells. In 2020, disitamab vedotin received FDA Breakthrough Therapy designation with the indication as second-line treatment for those with HER2- locally advanced urothelial cancer with previous exposure to platinum-containing chemotherapy. Seagen and RemeGen finalized a licensing agreement, valued at about $2.6 billion, for disitamab vedotin’s development and commercialization, in which Seagen pays $200 million to license its rights.
In clinical studies, disitamab vedotin has demonstrated antitumor activity in several solid tumor types, including urothelial, gastric, and breast cancer. Disitamab vedotin has already been approved for the treatment of HER2-positive gastric cancer in China and has been filed for HER2-positive bladder cancer. This medication has clearly shown efficacy and regulatory success in other countries. With potential success in the U.S., this medication has blockbuster potential as it is the jack of all trades. RemeGen and Seagen are targeting gastric, bladder and low HER2 breast cancer. Each indication could be worth $1 billion annually.
With the ever-growing market for breast cancer treatments, these three pipeline medications definitely have the potential to become a part of the standard of care (If it gets approved). Despite all the recent innovations, there are still unmet needs, which these three pipeline medications address. Even though time can only tell for FDA approval, these are the three to be on the lookout for.