Results of Phase III (PIX306) Trial Evaluating Progression-Free Survival of PIXUVRI® (pixantrone) Combined with Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma
SEATTLE, July 9, 2018 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) and Servier today announced that the pivotal Phase III trial (PIX306) evaluating PIXUVRI® (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of an improvement in progression-free survival (PFS).
"We are disappointed with the outcome of the PIX306 trial and will proceed to conduct a thorough review of clinical data to assess the next steps for the PIXUVRI program," commented Adam Craig, MD, PhD, CEO of CTI BioPharma. "We would like to express our appreciation to the patients, families and investigators who participated in the study."
Results from the study will be submitted to a peer-reviewed journal for publication.
The PIX306 trial enrolled 312 patients who had relapsed after therapy with CHOP-R or an equivalent regimen and were ineligible for stem cell transplant. The primary endpoint was progression-free survival (PFS) while overall survival (OS), complete response rate (CR), overall response rate (ORR) and safety were secondary endpoints.
For more information about the PIX306 trial, please visit
The ClinicalTrials.gov identifier is NCT01321541.
About Non-Hodgkin Lymphoma (NHL)
NHL can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.3 Around 168,000 new cases of NHL are diagnosed in the United States and Europe every year.
About PIXUVRI® (pixantrone)
PIXUVRI® has not been approved by the U.S. Food and Drug Administration in the United States (US).
PIXUVRI® has conditional marketing authorization from the European Commission for prescription in the European Union (EU) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL.6 Conditional marketing authorizations are granted in the EU if all the following requirements are met: the benefit-risk balance of the product is positive, it is likely that the applicant will be able to provide comprehensive data, unmet medical needs will be fulfilled, the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.7 The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018.
PIXUVRI® is mentioned in the ESMO guidelines as an anthracycline-like drug with reduced cardiotoxicity, which demonstrated some efficacy in heavily treated patients.8
The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI® in the approved indication. The SmPC is available at www.ema.europa.eu
CTI granted Servier rights to commercialize the drug globally in all markets except the US. The two companies continue to work closely to build the efficacy and safety evidence for PIXUVRI® and to ensure that as many eligible patients as possible are benefitting from it.
Becoming a key player in oncology is part of Servier's long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune, cellular and targeted therapies, to deliver life-changing medicines to patients.
About CTI BioPharma
(1) NHS Conditions webpage. NHL Cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed July 2018]. (2) Cancer Research UK. Lymphatic System. Available at http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer [last accessed July 2018]. (3) Cancer Research UK. What is NHL cancer. Available at http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/what-is-lymphoma [last accessed July 2018] 4 Pixuvri Summary of Product Characteristics, Available at: https://www.medicines.org.uk/emc/medicine/29829 [last accessed July 2018] 5 European Medicines Agency. About Pixuvri. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed July 2018]. 6 Evaluate Group. NICE Publishes Final Guidance on PIXUVRI(R) (pixantrone). Available at http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=490415 [last accessed July 2018]. 7 European Medicines Agency. Authorisation details. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed July 2018] 8 Tilly H et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology (2015). Volume 26 (suppl 5); v116-v125. Available at http://www.esmo.org/Guidelines/Haematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma [last accessed July 2018]
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