Phase I/IIa Combination Study of Bria-IMT™ with KEYTRUDA® in Advanced Breast Cancer
FDA has approved the combination study of Bria-IMT™ with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.). Patients will be eligible for combination therapy with Keytruda, depending on the type of breast cancer they have.
KEYTRUDA® Combination: Patients who show expression of PD-L1 or PD-L2 in their cancer will be treated with the combination of Bria-IMT™ and the anti-PD-1 antibody KEYTRUDA®.
More information on the roll-over combination study of Bria-IMT™ with pembrolizumab will be available on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03328026)
Rationale for the combination study of Bria-IMT™ with KEYTRUDA®
The immune checkpoint inhibitors such as pembrolizumab (KEYTRUDA®; anti-PD-1) have come to the forefront in the fight against cancer with substantial benefits for some patients. Most recently, the significance of immune checkpoint inhibitors was recognized by the Nobel committee by awarding Dr. Tasuku Honjo and Dr. James P. Allison with the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), validating the Company’s decision to launch a combination therapy with the immune checkpoint inhibitors.
Drs. Alison and Honjo independently, using different strategies, showed a new approach of treating patients by awakening certain cells of the immune system (T cells) to attack tumors. This new approach of treating patients with immune checkpoint inhibitors (such as KEYTRUDA®), designed to overcome immune suppression in cancer patients, is revolutionizing the fight against cancer.
In 2010 an important pre-clinical study by Dr. Allison’s group showed that combination with anti-PD-1 antibodies potentiated the tumor-destroying effect of melanoma cells engineered to produce granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system, compared to the treatment with the GM-CSF producing cells alone. Bria-IMT™ similarly uses a breast cancer cell line which produces GM-CSF. Bria-IMT™ has also been shown to indirectly and directly stimulate T cells, and hence boost the immune system. BriaCell has published these findings in a leading immunology journal. It is important to note that pembrolizumab has not been shown to work on its own in breast cancer but are approved for other indications. >
Manufactured by Merck & Co., Inc., KEYTRUDA® (pembrolizumab) is a prescription medicine that may treat certain cancers by working with the immune system. It has been approved for the treatment of a number of cancer indications excluding breast cancer. For more information on pembrolizumab, please see: http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf