ASCO Names CLL Therapies “Cancer Advance of the Year”

In its annual report on clinical advances in cancer, the American Society of Clinical Oncology (ASCO) has declared that the transformation in the treatment of patients with chronic lymphocytic leukemia (CLL) is the “advance of the year.” This is the first time ASCO has chosen to single out a particular advance in cancer treatment in its Annual Report on Progress Against Cancer.

Patients with CLL, the most common type of leukemia in adults, and their clinicians have seen four new therapies approved in just a 12-month time frame. There are an estimated 120,000 patients in the United States with CLL. A large proportion of these patients are diagnosed late in life and have few treatment options because they cannot tolerate the standard-of-care treatment of chemotherapy plus rituximab, according to the report.

About 16,000 people are diagnosed with CLL every year in the United States and about 4,400 people die from the disease.

“This has truly been a banner year for CLL and for clinical cancer research as a whole. Advances in cancer prevention and care, especially those in precision medicine, are offering stunning new possibilities for patients,” said ASCO president Peter P. Yu, MD, FACP, FASCO, in a statement announcing the annual report. “It’s also remarkable that almost one-third of the year’s top studies were made possible by federal research dollars. We cannot underestimate the importance of federal investment for answering critical cancer care questions, particularly in rare, under-studied cancers.”

The four CLL therapies include two immunotherapies-ofatumumab and obinutuzumab-as well as two targeted agents, idelalisib and ibrutinib.

Both immunotherapies are anti-CD20 antibodies approved in combination with chlorambucil for previously untreated patients with advanced CLL. The immunotherapy ofatumumab was approved by the US Food and Drug Administration in April 2014 after an initial accelerated approval in 2009. Obinutuzumab was approved in November 2013. Both therapies delay the progression of patients’ CLL by approximately 12 months.

The other agents are two different first-in-class targeted oral drugs. Idelalisib is a PI3K delta inhibitor, approved in July 2014 for relapsed, refractory CLL in combination with rituximab. Ibrutinib is a Bruton’s tyrosine kinase inhibitor, approved in February 2014 for CLL patients who carry a deletion in chromosome 17-a marker of poor prognosis.

All four agents are also approved in Europe.

“These new therapies fill an enormous need for thousands of patients living with CLL,” said Gregory Masters, MD, FACP, FASCO, ASCO expert and co-executive editor of the report. “For many older patients, especially, these drugs essentially offer the first chance at effective treatment, since the side effects of earlier options were simply too toxic for many to handle.”

Other Advances in Clinical Care

ASCO’s Annual Report on Progress Against Cancer also called for an increase in federal funding for medical research. The 2013–2014 ASCO president Clifford A. Hudis, MD, FACP, had previously submitted a testimony to the US Senate Committee on Appropriations, urging Congress to provide more investments into research, particularly in areas not well pursued by the private sector including pharmaceutical companies.

The report also highlighted prevention and screening advances, such as the use of anastrozole for breast cancer prevention in high-risk women as supported by clinical trials, as well as recommendations for lung cancer screening as outlined by the US Preventive Services Task Force.

The advances in patient care that were described in the report include the earlier initiation of palliative care to improve patient well-being, supported by palliative care studies of quality of life, as well as fertility preservation during breast cancer therapy with the use of the hormone drugs goserelin and triptorelin, with clinical evidence from the POEMS and PROMISE trials, respectively.

Other clinical advances highlighted were novel immunotherapies and advances for rare cancers, as well as advances in more common cancers such as prostate, lung, stomach, and thyroid.