Gielad presents follow-up data from idelalisib (zydelig®) registrational studies in patients with chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma

Gilead Sciences, Inc. (Nasdaq: GILD) today announced long-term follow-up results from the registration studies further describing the duration of response, progression-free survival (PFS) and the safety profile for idelalisib (Zydelig®) in patients with chronic lymphocytic leukemia (CLL) and two types of indolent non-Hodgkin lymphoma (iNHL).  The findings are being presented this week at the Annual Meeting of the American Society of Hematology (ASH).

In Europe, idelalisib is indicated in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy; or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.  Idelalisib has also been approved as a monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.¹ 

Indolent NHL and CLL are slow-growing, incurable blood cancers occurring typically in older individuals and can lead to life-threatening complications such as anemia, serious infection and bone marrow failure.^2-4  Relapse commonly occurs after initial chemo-immunotherapy^5,6 and many patients with relapsed disease are unable to tolerate chemotherapy, which may limit their treatment options.^7,8

“The results presented this week demonstrate the long-term benefit of idelalisib in patient populations that often have limited or no treatment options due to age or lack of response to existing therapies,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.  “As part of our ongoing effort to further define the safety and efficacy profile of idelalisib, we are continuing to pursue long-term follow-up studies and larger Phase 2 and Phase 3 clinical trials in combination with existing treatment regimens in both relapsed and first-line CLL and iNHL.”

References

1. European Medicines Agency. ZYDELIG (idelalisib) SPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003843/WC500175377.pdf. Accessed December 2014.
2. Chronic Lymphocytic Leukemia Treatment (PDQ). National Cancer Institute (NCI). Available at http://www.cancer.gov/cancertopics/pdq/treatment/CLL/healthprofessional/page1/AllPages. Accessed on October 31, 2014.
3. Adult Non-Hodgkin Lymphoma Treatment (PDQ). National Cancer Institute (NCI). Available at http://www.cancer.gov/cancertopics/pdq/treatment/adult-non-hodgkins/HealthProfessional/page1/AllPages. Accessed on October 31, 2014.
4. What you need to know about non-Hodgkin lymphoma. National Cancer Institute. September 2007.
5. Brown JR. Thetreatment of relapsed refractory chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program 2011;2011:110-8. doi: 10.1182/asheducation-2011.1.110.
6. Salles GA. Clinical Features, Prognosis and Treatment of Follicular Lymphoma. American Society of Hematology Education Program Book. 2007;2007:216-225.
7. Furman RR et al. Idelalisiband Rituximab in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med.  2014;370:997-1007.
8. Gopal AK et al. PI3Kδ inhibition byidelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370:1008-18.