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Eisai's Thyroid Cancer Drug Receives Early FDA Approval


The US Food and Drug Administration (FDA) has granted an early approval to Eisai’s drug for the most common form of thyroid cancer.  

The agency announced that it has approved the Japanese drugmaker’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). The drug won approval a full two months ahead of its already accelerated schedule and a day after detailed results were published in the New England Journal of Medicine (NEJM).

DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. The National Cancer Institute (NCI) estimates that 62,980 Americans were diagnosed with thyroid cancer and 1,890 died from the disease in 2014.

Lenvima is a tyrosine kinase receptor inhibitor that blocks the growth agents tumors need to grow and divide. The drug was reviewed under the FDA’s priority review program. Additionally, Lenvima was granted orphan product designation from the agency, since it is intended to treat a rare disease.

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”

The approval was based on data from a late-stage trial, which showed that the drug significantly improved progression-free survival (PFS) and overall response rate in this patient population

Earlier this week, an Eisai executive told the Wall Street Journal that the drug is expected to gross $1 billion per year by 2020. In addition to DTC, the company is also testing the drug for treatment of patients with hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and endometrial cancer.

Source: US Food and Drug Administration

Last updated: 2/13/15; 10:55am EST

New Affordable Care Act Initiative Aims to Improve Cancer Care and Cut Costs

Oncology Care Model

Today, the US Department of Health and Human Services (HHS) announced a cancer care initiative for Medicare beneficiaries that will link payments to oncology practices to quality of care and patient outcomes.

The New Affordable Care Act initiative, by the Centers for Medicare and Medicaid Services (CMS), is in support of the ongoing effort to improve the quality of care patients receive and spend health care dollars more wisely. The initiative will include 24-hour access to practitioners for beneficiaries undergoing treatment and an emphasis on coordinated, person-centered care, aimed at awarding value of care, rather than volume.

“Based on feedback from the medical, consumer and business communities, we are launching this new model of care to support clinicians’ work with their patients,” said Dr. Patrick Conway, chief medical officer of CMS. “We aim to provide Medicare beneficiaries struggling with cancer with high-quality care around the clock and to reward doctors for the value, not volume, of care they provide. Improving the way we pay providers and deliver care to patients will result in healthier people.”

Cancer is one of the most common and devastating diseases in the US, with more than 1.6 million Americans diagnosed with the disease each year. The National Institutes of Health (NIH) estimated that cancer cost the US $263.8 billion in medical costs and lost productivity in 2010. The majority of individuals diagnosed are over 65 years old and Medicare beneficiaries.

CMS said it has determined that a new way of paying for and delivering cancer care is needed. CMS Innovation Center developed the Oncology Care Model as an innovative payment and care delivery model, created in response to feedback from the oncology community. The model will invest in physician-led practices. The Oncology Care Model encourages participating practices to improve care and lower costs through episode-based, performance-based payments that financially incentivize high-quality, coordinate care. Practices that participate will also receive monthly care management payments for each Medicare fee-for-service beneficiary during an episode to support oncology practice transformation.

The HHS is focused on three areas including linking payment to quality of care, improving and innovating in care delivery, and sharing information more broadly to providers, consumers, and others to support better decisions while maintaining privacy.

“With the Oncology Care Model, CMS has the opportunity to achieve three goals in the care of this medically complex population who are facing a cancer diagnosis: better care, smarter spending, and healthier people,” said Dr. Conway. “As a practicing physician and son of a Medicare beneficiary who died from cancer, I know the importance of well-coordinate care focused on the patient’s needs.”

CMS hopes to broaden the initiative to include a larger portion of the population through participation of Medicaid programs and non-government payers. Physician group practices and solo practitioners that provide chemotherapy for cancer and are enrolled in Medicare may apply to participate.

Source: Centers for Medicare & Medicaid Services

Last updated: 2/12/15; 3:45pm EST

Eisai's Lenvatinib Succeeds in Late-Stage Thyroid Cancer Trial


In a late-stage study, led by researchers at the University of Texas MD Anderson Cancer Center, Eisai’s investigational thyroid cancer drug significantly improved progression-free survival (PFS).

Eisai announced that results from the Phase III SELECT trial, evaluating lenvatinib, a novel investigative anticancer agent for patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC), were published in the New England Journal of Medicine.

According to MD Anderson, the investigational drug could offer a new treatment paradigm for a group of patients, whom, until recently, there has been no new effective treatment since the 1940s.

“For decades, in this patient population, the treatment was often to repeat ineffective doses of radio-active iodine, and possibly salvage therapy with chemotherapy,” Sherman said. “About 10 years ago, with the growing availability of novel targeted agents and multi-targeted kinase inhibitors, we began to recognize potential for treating this subgroup of patients with anti-angiogenic therapy and sought to enroll those with refractory disease in clinical trials.”

The global study, led by Steven I. Sherman, MD, associate vice-provost for Clinical Research, and professor and chair, Endocrine Neoplasia and Hormonal Disorders, MD Anderson, included 392 patients who were randomized to receive lenvatinib or placebo. In the study, lenvatinib demonstrated a statistically significant extension in PFS compared to placebo, the primary endpoint of the study, with a median PFS in the lenvatibin group of 18.3 months and a median PFS in the placebo group of 3.6 months. Additionally, lenvatinib demonstrated a statistically significant improvement in overall response rate (ORR) compared to placebo, with a 64.8 percent ORR in the lenvatinib group compared to only 1.5 percent in the placebo group.

“In our study, we not only saw a dramatic improvement in progression-free survival, there was also a 65 percent response rate – almost unprecedented results for thyroid cancer patients with such advanced disease. We also found a strongly suggestive trend in how long patients lived, and a small number of patients had a complete response. While we couldn’t identify tumor mutations that might predict response, this represents a very exciting area of study going forward in hopes of possibly offering cure to a greater number of patients,” Sherman said.

The drug was associated with side effects. More than 40 percent of patients in the lenvatinib group experienced some reaction, with hypertension being the most common, followed by diarrhea, fatigue or asthenia, decreased appetite, weight loss and nausea.

Eisai submitted data to regulators last year. The drug was granted Orphan Drug Designation and Priority Review status by the US Food and Drug Administration (FDA). With the agency’s accelerated assessment, the FDA is expected to make a final decision on whether to approve the drug in the next few months.

Eisai is also studying the drug for treatment of patients with hepatocellular carcinoma (HCC), renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). According to Eisai Executive, Ivan Cheung, the company expects the drug to be a blockbuster, generating sales of more than $1 billion by 2020. 

Sources: University of Texas MD Anderson Cancer Center; Eisai Co., Ltd.; Wall Street Journal

Last updated: 2/12/15; 10:30am EST

Advaxis and Incyte Strike Cancer Immunotherapy Deal


Advaxis, Inc. has signed a deal with Incyte Corporation to evaluate the combination of the companies’ investigational cancer immunotherapies.

The companies announced that they have entered into a clinical trial collaboration agreement to study the combination of Advaxis’ Lm-LLO cancer immunotherapy, ADXS-HPV (ADXS11-001), with Incyte’s oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360). The Phase II study will evaluate the safety and efficacy of ADXS-HPV as a monotherapy and in combination with Incyte’s drug in twenty patients with Stage I-IIa human papillomavirus (HPV)-associated cervical cancer.

Under the terms of the agreement, the companies will work together to conduct the mid-stage study, and will split the associated costs. Advaxis and Incyte said they expect initiation of the study to begin later this year, and results will be used to determine whether the combination should advance into Phase III.

“We are excited to collaborate with Incyte and to evaluate epacadostat in combination with our leading Lm-LLO immunotherapy candidate, ADXS-HPV,” said Daniel J. O’Connor, Chief Executive Officer of Advaxis. “In previous and ongoing studies, a single treatment cycle ofADXS-HPV, as a monotherapy, has demonstrated improvements in overall survival in women with recurrent cervical cancer. WE believe the combination of immunotherapies may hold significant promise for the treatment of difficult-to-treat disease.”

ADXS-HPV is Advaxis’ lead immunotherapy product candidate for treating HPV-associated cancers, which is currently being studied in three HPV-associated cancers including invasive cervical cancer, head and neck cancer and anal cancer. In a recently completed mid-stage trial, ADXS-HPV showed apparent prolonged survival and tumor responses, including complete responses, as well as a manageable safety profile both as a monotherapy and in combination with chemotherapy. The drug has received orphan drug designation from the US Food and Drug Administration (FDA) for ADXS-HPV to treat invasive cervical cancer, HIV-associated head and neck cancer and anal cancer.

Epacadostat is an orally bioavailable small molecule inhibitor of IDO1, which is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allows tumors to escape immune surveillance. The drug has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer types.

“We believe immune-targeted combination therapy represents a promising new approach in oncology,” said Rich Levy, MD, Chief Drug Development and Medical Officer at Incyte. “This clinical trial collaboration is a further illustration of our desire to investigate the therapeutic value of our IDO1 inhibitor in multiple tumor types as rapidly as possible.”

The companies did not disclose financial details of the agreement.

Source: Advaxis, Inc.

Last updated: 2/11/15; 1:30pm EST

Wake Forest Baptist Medical Center Launches Precision Medicine Program

Wake Forest Baptist Medical Center

In an effort to personalize medicine, Wake Forest Baptist Medical Center announced a new Precision Medicine program at its cancer center.

Precision medicine, introduced to the nation during President Barack Obama’s State of the Union address, uses a person’s unique genetic makeup to develop an individualized treatment plan. For cancer, oncologists identify the cancer-associated genes in an individual’s tumor, a process known as genomic sequencing, to pinpoint the individual’s genetic drivers that fuel cancer growth. A unique treatment plan is then designed around the genetic abnormalities and mutations in the person’s tumor.

The new Precision Medicine program will be at Wake Forest Baptist Medical Center’s National Cancer Institute-designated Comprehensive Cancer Center.

“This is an exciting time for us,” said Boris Pasche, MD, director of the Comprehensive Cancer Center. “We have developed one of the most comprehensive, coordinated efforts around precision medicine. Some of our adult and pediatric patients could greatly benefit from unique therapies in cases that are not responding to standard treatments.”

Precision medicine treatments area ideal for patients with either end-stage cancer, an active cancer that has failed standard therapy, or cancer that is likely to progress despite standard therapies. The approach is not for every cancer patient, since some patients may have cancer with a genetic makeup for which there is no current appropriate precision medicine therapy available. The most common cancers for which genomic sequencing is available include metastatic breast cancer, metastatic colon cancer, lung cancer not successfully removed by surgery, esophageal cancer, abdominal cancers (pancreatic, appendiceal and stomach), advanced prostate cancer, metastatic melanoma and leukemia.

According to Pasche, the goal of precision medicine is to select the most appropriate therapy for each patient’s cancer so they can have the potential of improved health or a longer life, and although it may be an effective alternative to standard chemotherapy, it is not necessarily a stand-alone cure.

Some insurance companies and government payers cover precision medicine treatments on a case-by-case basis. According to the company, nationally, more third-party payers are seeing the value of precision medicine for patients with end-stage cancer since it often offers a therapy that may cost less than re-hospitalization.

“As the only Comprehensive Cancer Center in western North Carolina, we have access to therapies that other facilities do not. Genomic sequencing also means our patients can be better matched to existing and new clinical trials,” said Pasche.

Source: Wake Forest Baptist Medical Center

Last updated: 2/11/15; 11:50am EST