KEYNOTE-890 is designed to evaluate TAVO™ in Combination with Merck's KEYTRUDA® (pembrolizumab) for the Treatment of Late-Stage Triple Negative Breast Cancer.
SAN DIEGO and PENNINGTON, N.J., /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, today announced that the first patient has been treated in KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO™ (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck's KEYTRUDA® (pembrolizumab).
KEYNOTE-890 is designed as a multicenter Phase 2 open-label trial focusing on patients with a histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. 25 patients are expected to be enrolled. Each patient will undergo 3-week treatment cycles with pembrolizumab administered as a 30-minute IV infusion day 1 of every cycle (flat dose of 200 mg) and treated with TAVO™ on days 1, 5 and 8 every six weeks.
"Treating the first patient in our KEYNOTE-890 clinical trial is an important milestone for OncoSec as we seek to rapidly advance this program," said Kellie Malloy Foerter, Chief Clinical Development Officer of OncoSec. "Additionally, this study is important for patients with metastatic triple negative breast cancer given the lack of treatment options currently available. Prior clinical observations suggest that TAVO™ in combination with pembrolizumab is a valid therapeutic approach for TNBC. Based on the outcome of the study and feedback from FDA, we may choose to expand the study and seek accelerated approval with the FDA for this patient population."
Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 10-20 percent of U.S. breast cancer cases are triple negative breast cancer (TNBC),1 which disproportionately affects younger women, as well as African-American women,2 followed by Hispanic women.3
TNBC remains a poor-prognosis breast cancer subtype,2 with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC.5-8 Preliminary data from early-phase studies demonstrated the anti-PD-1 antibody pembrolizumab led to an objective response in 18 to 19 percent of TNBC patients;5-7 and median overall survival was 8.9 months in a pretreated cohort.6 The anti-PD-L1 antibody atezolizumab (MPDL3280A) achieved an objective response in 25 percent of patients in the first-line and 11 percent of patients in the second-line setting.8 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective.9-12 Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.13-17
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "can," "may," "will," "suggest," "look forward to," "potential," "understand," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec's filings with the Securities and Exchange Commission.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
1. BreastCancer.org. Triple Negative Breast Cancer. http://www.breastcancer.org/symptoms/diagnosis/trip_neg. Accessed September 7, 2015.
2. Bauer KR, et al., "Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer Registry." Cancer. 2007 May 1; 109(9):1721-8.
3. BreastCancer.org. Who Gets Triple Negative Breast Cancer? http://www.breastcancer.org/symptoms/diagnosis/trip_neg/who_gets. Accessed September 7, 2015.
4. F Andre and CC Zielinski. "Optimal strategies for the treatment of metastatic triple-negative breast cancer with currently approved agents." Annals of Oncology, 2012. 23(6): vi46-vi51.
5. Nanda R, et al., "A phase Ib multicohort study of MK-3475 in patients with advanced solid tumors." Journal of Clinical Oncology, 2014. 32:5s (suppl; abstr PS3119).
6. Targetedonc.com. Checkpoint Inhibitors Moving Ahead in Breast Cancer http://www.targetedonc.com/conference/ibc-2017/checkpoint-inhibitors-moving-ahead-in-breast-cancer
7. Emens LA, et al., "Inhibition of PD-L1 by MPDL3280A leads to clinical activity in patients with metastatic triple-negative breast cancer." San Antonio Breast Cancer Symposium, 2014.
8. Mahmoud SM, et al., "Tumor-infiltrating CD8+ lymphocytes predict clinical outcome in breast cancer." Journal of Clinical Oncology, 2011. 29(15): p. 1949-55.
9. Adams S, et al., "Prognostic value of tumor-infiltrating lymphocytes in triple-negative breast cancers from two phase III randomized adjuvant breast cancer trials: ECOG 2197 and ECOG 1199." Journal of Clinical Oncology, 2014. 32(27): p. 2959-66.
10. Loi S, et al., "Tumor infiltrating lymphocytes are prognostic in triple negative breast cancer and predictive for trastuzumab benefit in early breast cancer: results from the FinHER trial." Annals of Oncology, 2014. 25(8): p. 1544-50.
11. Loi S, et al., "Prognostic and predictive value of tumor-infiltrating lymphocytes in a phase III randomized adjuvant breast cancer trial in node-positive breast cancer comparing the addition of docetaxel to doxorubicin with doxorubicin-based chemotherapy: BIG 02-98." Journal of Clinical Oncology, 2013. 31(7): p. 860-7.
12. Denkert C, et al., "Tumor-associated lymphocytes as an independent predictor of response to neoadjuvant chemotherapy in breast cancer." Journal of Clinical Oncology, 2010. 28(1): p. 105-13.
13. Denkert C, et al., "Tumor-infiltrating lymphocytes and response to neoadjuvant chemotherapy with or without carboplatin in human epidermal growth factor receptor 2-positive and triple-negative primary breast cancers." Journal of Clinical Oncology, 2014.58.1967.
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