Etirinotecan pegol is the first long-acting topoisomerase-I inhibitor that concentrates in tumor tissue and provides sustained tumor suppression throughout the entire chemotherapy cycle.
"For patients with relapsed small-cell lung cancer, prognosis is poor with second-line therapy," said Dr. Adjei. "Approved topoisomerase-I inhibitors have demonstrated anti-tumor activity in small-cell lung cancer, but their use is often hampered by significant toxicity and pharmacokinetics. Given this background, we are very interested in evaluating etirinotecan pegol as a potential treatment option for this patient population."
The primary endpoint of the phase II study is the 18-week progression-free survival (PFS) rate. Secondary endpoints include objective response rate (ORR), overall survival (OS), median duration of response (DoR) and the safety profile of etirinotecan pegol in patients with relapsed SCLC. This single-stage study will evaluate etirinotecan pegol in two patient cohorts: chemo-resistant (those progressing within three months after completing first-line therapy) and chemo-sensitive (those progressing at three months or later after completing first-line therapy). The study is expected to enroll approximately 38 patients who will receive etirinotecan pegol once every three weeks as monotherapy.
"We are very pleased that Dr. Adjei has identified and proposed this study of single-agent etirinotecan pegol in this difficult to treat patient population," said
About SCLC
Small-cell lung cancer (SCLC) is one of the most aggressive and lethal cancers in humans. It accounts for 15-20% of all lung cancer. Although standard combination cytotoxic chemotherapy agents have shown antitumor activity with initial responses of 70%—90% for both limited and extensive stages of SCLC, long-term survival is low and most patients eventually develop progressive disease within the first 2 years.1-3 Consequently, there is a need for new therapies that are safe and effective, which also improve overall survival and quality of life.
About Etirinotecan Pegol
Etirinotecan pegol is a unique, targeted topoisomerase-I inhibitor designed for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate the vasculature of the tumor environment more readily than normal vasculature, increasing the concentration of active drug within tumor tissue to enhance antitumor activity. The BEACON study is a Phase 3 clinical study currently evaluating etirinotecan pegol for the treatment of locally recurrent or metastatic breast cancer. In addition to metastatic breast cancer, etirinotecan pegol is also being evaluated for the treatment of ovarian, colorectal, high-grade glioma and non-small-cell lung cancers.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "could," "potential," "may" and similar references to future periods. Examples of forward-looking statements include our current views regarding etirinotecan pegol as a potential new therapy for cancer patients; the value of our advanced polymer conjugate technology platform; and the potential of certain of our other drug candidates and those of our collaboration partners. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, observations and assumptions regarding the potential of our drug candidates and our technology.
Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) etirinotecan pegol is still in clinical development and the risk of failure is high and can unexpectedly occur at any time prior to regulatory approval for numerous reasons including safety and efficacy findings from the ongoing BEACON Phase 3 clinical study; (ii) the statements regarding the therapeutic potential of etirinotecan pegol are based on
preclinical data and data from completed Phase 2 clinical studies and future clinical study results may not confirm these earlier findings; (iii) the timing of the commencement or end of clinical trials, target timeframe for the availability of clinical results, and the successful commercial launch of our drug candidates may be delayed or unsuccessful due to manufacturing challenges, changing standards of care, regulatory delay, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of our technology platform to potential new drug candidates such as etirinotecan pegol is therefore very uncertain and unpredictable and
could unexpectedly fail at any time; (v) patents may not issue from our patent applications for etirinotecan pegol, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; (vi) the outcome of any existing or future intellectual property or other litigation related to our proprietary drug candidates; and (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the
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References
- Jett JR, Everson L, Therneau TM, et al., Treatment of limited-stage small-cell lung cancer with cyclophosphamide, doxorubicin, and vincristine with or without etoposide: a randomized trial of the
North Central Cancer Treatment Group . J Clin Oncol. 1990 Jan;8(1):33-8. - Livingston RB, et al., Small-cell carcinoma of the lung: combined chemotherapy and radiation: a
Southwest Oncology Group study. Ann Intern Med. 1978 Feb;88(2):194-9. - Maksymiuk, AW, et al., Sequencing and schedule effects of cisplatin plus etoposide in small-cell lung cancer: results of a
North Central Cancer Treatment Group randomized clinical trial. J Clin Oncol. 1994 Jan;12(1):70-6.
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