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CytRx to present phase 3 aldoxorubicin clinical data in patients with soft tissue sarcomas at 2017 ASCO meeting

Los Angeles
Friday, May 19, 2017, 15:00 Hrs  [IST]

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, has announced the presentation of two abstracts at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2017 in Chicago. The first is an oral presentation featuring updated and more detailed results from the company's global phase 3 clinical trial evaluating aldoxorubicin versus investigator's choice in patients with relapsed and refractory soft tissue sarcomas (STS). The other is a poster presentation describing updated data from an ongoing phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna (I-M) in first- and second-line STS.

"In addition to the significantly prolonged progression-free survival achieved by both North American and L-sarcoma patients, the data presented at ASCO this year demonstrate that, unlike any other drugs in this class, aldoxorubicin can be dosed continuously with minimal to no cardiotoxicity," commented Sant Chawla, M.D., F.R.A.C.P., director of the Sarcoma Oncology Center in Santa Monica, California, and Principal Investigator for the Phase 3 trial.  "Another distinct advantage is its ability to be administered to patients who have already been treated with doxorubicin.  Taken together, these findings support aldoxorubicin's potential as a superior anthracycline treatment for patients suffering with these highly complex and difficult to treat types of cancer."

Daniel Levitt, M.D., Ph.D., chief operating officer and chief medical officer of CytRx, commented, "The data from both of these important clinical trials evaluating aldoxorubicin in sarcomas, along with our several other completed clinical and preclinical studies, will form the basis of our planned New Drug Application submission to the US Food and Drug Administration, and we are pleased to share these more mature and detailed results in this peer-reviewed forum with the medical and scientific communities."

This multicenter, randomized, open-label Phase 3 trial enrolled 433 patients at 79 sites. The data summarized here are as of August 2016. In patients with leiomyosarcoma and liposarcoma (n=246), aldoxorubicin demonstrated median progression-free survival (PFS) of 5.32 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 2.36 months (p=0.007; hazard ratio (HR)=0.62, 95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression.  In patients treated in North America plus Australia (n=312), aldoxorubicin demonstrated a median PFS of 4.21 months, compared to a median PFS of 2.96 months for investigator's choice therapy, a statistically significant improvement of 1.25 months (p=0.023, HR=0.71, 95% CI 0.53-0.96). In the overall intent to treat (ITT) trial population (n=433), aldoxorubicin performed better than investigator's choice demonstrating a median PFS of 4.11 months, compared to a median PFS of 2.96 months for investigator's choice therapy, narrowly missing statistical significance (p=0.087; HR=0.81, 95% CI 0.64-1.03). All responses in this study were determined by an independent, blinded central lab assessment of scans.

Key safety findings included that aldoxorubicin caused no clinically significant cardiac, renal, or hepatic toxicities.  Aldoxorubicin administered at 350mg/m2 per cycle showed no cardiotoxicity up to 40 cycles.  Importantly, left ventricular ejection fraction (LVEF) below 50% of expected values were reported in 4.2% of patients treated with aldoxorubicin, compared to 19.1% for patients receiving investigator's choice.  Additionally, =20% decreases in LVEF from baseline were reported in 3.8% of patients treated with aldoxorubicin, compared to 8.5% for patients receiving investigator's choice.  For the global trial population, the most commonly reported (=10%) Grade =3 adverse events were neutropenia, anemia, febrile neutropenia, stomatitis and decreased white blood cell count, and were manageable with standard supportive care.  The non-cardiac Grade =3 adverse events associated with aldoxorubicin were similar to doxorubicin despite exposure up to 3-4 times the standard doxorubicin dose.

Updated data relating to the trials other secondary endpoints, including objective response rate (ORR), disease control rate (DCR), overall survival, and other safety parameters were in line with what has previously been reported by CytRx and will be included in the oral presentation being given at ASCO 2017.


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