Studies Support Growing Use of the Accuray TomoTherapy® System for Breast Cancer to Improve Tumor Control with Reduced Toxicities

Studies Support Growing Use of the Accuray TomoTherapy® System for Breast Cancer to Improve Tumor Control with Reduced Toxicities

SUNNYVALE, Calif., September 18, 2014 – Accuray Incorporated (Nasdaq: ARAY) announced today that studies presented at the 56th Annual American Society for Radiation Oncology (ASTRO) Meeting in San Francisco, September 14–17, 2014 continue to reinforce broad-based healthcare professional support of the clinical and quality of life benefits the CyberKnife® and TomoTherapy® Systems deliver. A variety of indications including breast, prostate, lung, brain, and head and neck cancers were featured at the meeting, further positioning Accuray as a leader in precise, innovative tumor treatments.

ASTRO 2014 TomoTherapy clinical presentations focused on treatment of breast, brain, and head and neck cancers, and showed the system’s versatility, efficiency and effectiveness as a treatment for routine or more complex cases. Further information on this system is available at http://www.accuray.com/solutions/treatment-delivery/tomotherapy-treatment-delivery/h-series.

• A notable study [i] highlighted results from an interim report of an ongoing IRB-approved phase 2 study on accelerated partial breast irradiation (APBI). With a median follow-up of 24 months, data supports the use of TomoTherapy for APBI based on its ability to provide patients with decreased mean radiation dose to the heart (0.6 Gy) while providing meaningful local tumor control.
• A study [ii] on the use of helical radiation therapy to deliver a simultaneous integrated boost (SIB) during breast cancer treatment concluded, “Helical TomoTherapy is capable of delivering homogeneous treatment plans to the whole breast and lumpectomy cavity using SIB with acceptable acute toxicity.” At three and six month follow-ups, patients had minimal residual erythema with all patients either having grade 0 or grade I symptoms, and there were no grade 2 or grade 3 toxicities reported at any endpoint.
• A third study [iii] showed a four-fraction stereotactic radiosurgery (SRS) protocol using TomoHelical delivery mode provided excellent tumor control of brain metastases with minimal toxicity, even in patients with multiple tumors or those with large gross tumor volumes.
• An additional study [iv] showcased results of a Pareto optimality algorithm developed to identify optimal plans across 40 head and neck cases with lower-neck tumors; each case was randomly assigned and planned with the TomoTherapy System, conventional fixed gantry IMRT, and RapidArc®. The study found that more than half of the Pareto optimal plans were generated for the TomoTherapy System, with conventional delivery systems dividing the rest, reinforcing the precise, efficient treatment planning capabilities of the TomoTherapy System.

ASTRO 2014 CyberKnife presentations focused on a range of indications including lung, brain, and prostate cancer and highlighted the benefits of a system that automatically tracks the tumor and adjusts the beam, maximizing the dose delivered to the tumor and minimizing side effects.

Further information on this system is available at http://www.accuray.com/solutions/treatment-delivery/cyberknife-treatment-delivery/m6-series.

• One [v] study of patients with stage 1 non-small-cell lung cancer found that even those with comorbidities, such as chronic obstructive pulmonary disease, experienced excellent rates of disease control including regional failure free survival, distant metastasis free survival and overall survival, with very little toxicity.
• Another study [vi] evaluated fractionated stereotactic radiosurgery (F-SRS) versus single-fraction radiosurgery (S-SRS) for the treatment of brain metastases. Use of F-SRS resulted in similar local tumor control and safety profile despite a patient population consisting of larger tumors and worse prognostic factors, indicating that treatment with F-SRS may enable clinicians to expand their patient population.
• Several presentations of CyberKnife SBRT continue to validate this precise, innovative approach to the treatment of prostate cancer. Two retrospective analyses [vii] reinforce the use of CyberKnife for the treatment of prostate cancer. One study found patients with low to intermediate-risk prostate cancer experienced a high rate of biochemical progression free survival with acceptable toxicity and PSA levels that often continued to decline beyond two years post-treatment.

Another showed use of SBRT as salvage therapy following the recurrence of prostate cancer provides similar efficacy and toxicity to low and high dose rate interstitial brachytherapy, with the significant advantage of being a non-invasive treatment.

Abstracts can be found on the website of the International Journal of Radiation Oncology Biology Physics: https://www.redjournal.org/

“We’re excited to see data show the TomoTherapy System provides significant clinical benefits for breast cancer patients and long-term data continue to support the use of the CyberKnife System as a treatment for prostate cancer,” said Joshua H. Levine, president and chief executive officer of Accuray. “In addition, we’re encouraged by customer feedback on the new platforms indicating these systems can increase throughput and broaden clinical utility, enabling more patients to receive precisely targeted radiation treatments.”

About the CyberKnife® and TomoTherapy® Systems

The Accuray CyberKnife M6™ Series and TomoTherapy H™ Series treatment solutions cover the entire spectrum of radiation therapy needs. The CyberKnife M6 Series enables precise, high quality, dose distributions to be confidently delivered to the patient with extreme accuracy over a minimum number of treatments, reducing side effects and preserving patients’ quality of life. The CyberKnife System is the only robotic full-body radiosurgery system available today. The TomoTherapy H Series efficiently enables physicians to customize treatment plans for the entire range of radiation therapy patients and disease types. Its innovative design enables treatment plans to be delivered with integrated, daily CT image guidance, enhancing accuracy and delivering highly precise, intensity-modulated radiation for optimal sparing of healthy tissue and critical structures.

About Accuray

Accuray Incorporated (Nasdaq: ARAY) is a radiation oncology company that develops, manufactures and sells precise, innovative tumor treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The company’s leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. For more information, please visit www.accuray.com.

Safe Harbor Statement

Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to clinical experience, clinical applications, clinical results, patient outcomes, and Accuray’s leadership position in radiation oncology innovation and technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to the risks detailed under the heading “Risk Factors” in the company’s report on Form 10-K, filed on August 29, 2014, and the company’s other filings with the SEC.

Forward-looking statements speak only as of the date the statements are made and are based on information available to the company at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements.

Abstracts

[i] de Paula, U. et al., Full Local Control With Accelerated Partial Breast Irradiation (APBI) by Tomotherapy After Breast-Conservative Surgery for Patients Suitable, or Not, According to ASTR0-2009 Consensus Statement: Interim Report After 2 Years Follow-Up. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14–17, 2014.

[ii] Wojcieszynski, A. et al., Toxicity From Breast Cancer Treatment Using Helical Intensity Modulated Radiation Therapy With an Incorporated Boost. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14–17, 2014.

[iii] Nagai, A. et al., Hypofractionated Stereotactic Radiation Therapy Using Helical Tomotherapy for Single or Multiple Brain Metastases. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14–17, 2014.

[iv] Ruan, D. et al., A Pareto Optimality Test Scheme and its Utilization to Assess Systematic Variation of Plan Quality Across Treatment Modalities. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14–17, 2014.

[v] Samuelian, J.M., Curative Treatment of Stage I Non-Small Cell Lung Cancer Using Robotic Stereotactic Radiation in Patients With COPD: A VA Population Study. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14–17, 2014.

[vi] Savir, G. et al., Comparison of Fractionated Stereotactic Radiosurgery and Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14–17, 2014.

[vii] Lloyd, S. et al., Robotic Stereotactic Body Radiation Therapy for Prostate Adenocarcinoma. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14 – 17, 2014. Fuller, D.B. et al., HDR-Like SBRT for Post-Radiation Therapy Locally Recurrent Prostatic Carcinoma: PSA Response, DFS, and Toxicity Assessment. 56th Annual American Society for Radiation Oncology (ASTRO) Meeting, San Francisco, California, September 14–17, 2014.