publication date: Apr. 5, 2019
Drugs & Targets
Varian ARIA Oncology Information System awarded CancerLinQ certification
The number of electronic health record systems joining with CancerLinQ to facilitate information sharing continues to grow. CancerLinQ LLC, a wholly owned nonprofit subsidiary of the American Society of Clinical Oncology, announced Varian’s ARIA Oncology Information System is the next Electronic Health Record System to be certified by CancerLinQ after meeting criteria for interoperability and data standardization. This collaboration aims to dismantle barriers to information sharing and streamline access to CancerLinQ for oncology practices using Varian ARIA OIS.
ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology.
The ARIA system is designed to provide a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up.
CancerLinQ is a health information technology platform working to improve the quality of cancer care for patients by aggregating and analyzing real-world cancer data. The CancerLinQ Certified EHR program recognizes systems that meet specific requirements for interoperability and cancer data standardization.
To become a CancerLinQ Certified EHR and maintain this status, an EHR system must do the following, in addition to fulfilling other requirements:
Support the creation and maintenance of health records including, but not limited to, individually identifiable oncology and/or hematology patient information;
Maintain a leading industry standard for the recording of precise, structured, and standardized clinical data;
Meet certain federal standards for EHR technology, interoperability, privacy, and safety;
Work to achieve the continuous, secure transfer of data to the CancerLinQ system from patients associated with practices that both participate in CancerLinQ and use the EHR; and
Participate in efforts among stakeholders in the cancer community to drive improvement of interoperability, establish core data elements, and support efforts to standardize and harmonize data approaches.
FDA expands use of metastatic breast cancer treatment to include male patients
FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients.
The drug is sponsored by Pfizer.
“Today we are expanding the indication for Ibrance to include male patients based upon data from postmarketing reports and electronic health records showing that the safety profile for men treated with Ibrance is consistent with the safety profile in women treated with Ibrance,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Some approved indications for breast cancer treatments do not distinguish by gender, but in certain cases if there is a concern that there may be a difference in efficacy or safety results between men and women, then further data may be necessary to support a labeling indication for male patients.”
Breast cancer is rare in males with only 2,670 cases of male breast cancer estimated in 2019 – less than 1% of all cases of breast cancer. The majority of breast tumors in male patients express hormone receptors.
Men are more likely to be diagnosed at an older age, with a more advanced stage of disease. Metastatic breast cancer is breast cancer that has spread beyond the breast to other organs in the body (most often the bones, lungs, liver, or brain).
When breast cancer is hormone-receptor positive, patients may be treated with hormone therapy (also called endocrine therapy) or chemotherapy. Endocrine therapy slows or stops the growth of hormone-sensitive tumors by blocking the body’s ability to produce hormones or by interfering with effects of hormones on breast cancer cells.
There are several FDA-approved endocrine based therapies available for HR-positive metastatic breast cancer patients. Certain treatments are gender-neutral in their indication, but some therapies have been approved only for women, although they are often prescribed for male patients. According to the current clinical practice standards, male patients with breast cancer are treated similarly to women with breast cancer.
Ibrance was initially approved in 2015. It is a kinase inhibitor, approved in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with fulvestrant in patients whose disease progressed following hormonal therapy.
Pfizer provided the results of an analysis of real-world data from electronic health records as additional supportive data to characterize the use of palbociclib in combination with endocrine therapy (aromatase inhibitor or fulvestrant) in male patients with breast cancer based on observed tumor responses in this rare subset of patients with breast cancer.
FDA issues warning letter to genomics lab for marketing genetic test that claims to predict patients’ responses to specific medications
FDA issued a warning letter to Inova Genomics Laboratory of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. The tests claim to predict patients’ responses to specific medications based on genetic variants.
Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients. The FDA is unaware of any data establishing that Inova’s tests can help patients or health care providers make appropriate treatment decisions for the listed drugs.
The action today reflects the agency’s commitment to monitor the pharmacogenetic test landscape and take action when appropriate to address a significant public health risk.
That letter can be found here.
When the agency has reviewed scientific evidence demonstrating a sufficient relationship between the drug’s effects and genetic variants, information about using genetic test results to manage medication treatment will be described in the labeling.
Nanobiotix receives European approval for Hensify therapy for sarcoma
Nanobiotix announced Hensify (NBTXR3) has obtained a CE mark for the treatment of locally-advanced soft tissue sarcoma. Hensify is the brand name for NBTXR3 as approved for the treatment of locally-advanced STS.
Hensify was designed by Nanobiotix to physically destroy tumor and activate the immune system for both local control and systemic disease treatment when combined with radiation therapy. In addition to Hensify, NBTXR3 is currently under evaluation in various other indications such as lung cancer, head and neck cancers, liver cancer, and prostate cancer.
Hensify is an aqueous suspension of crystalline hafnium oxide nanoparticles designed for injection directly into a tumor prior to a patient’s first standard radiotherapy treatment. When exposed to ionizing radiation, Hensify amplifies the localized, intratumor killing effect of that radiation.
The dose of X-ray delivered to the tumor is magnified, whilst the dose passing through healthy tissues remains unchanged. Hensify requires a single administration and will fit into current worldwide standards of radiation care.
STSs are rare cancers that develop in different types of soft tissues including fat, muscles, joint structures and blood vessels. Radiotherapy followed by surgery is part of the typical treatment regimen for STS patients in Europe.
The Act.In.Sarc phase II/III trial was a prospective, randomized (1:1), multinational, open label and active controlled two armed trial of 180 adult patients with locally advanced STS of the extremity or trunk wall. The objective of the trial was to evaluate the pre-operative efficacy and the safety of Hensify activated by radiotherapy compared to the standard of care (radiotherapy alone).
The positive Act.In.Sarc study results were presented at the 2018 ASTRO and ESMO Annual Congresses. The trial achieved its primary endpoint with a pathological complete response (<5% viable cancer cells) rate of 16.1% in the Hensify arm compared to 7.9% in the control arm (p=0.0448).
In addition, in the subgroup of patients with a more aggressive disease (histologic grade 2 and 3), a pathological complete response was achieved in four times as many patients in the Hensify® arm as in the control arm (17.1% compared 3.9%).
Similar safety profiles were observed in the Hensify arm and the radiation therapy alone control arm. Hensify did not impair the patients’ ability to receive the planned dose of radiotherapy and the radiotherapy safety profile was similar in both arms, including the rate of postsurgical wound complications.
Post-approval trials are planned across Europe and discussions on next steps regarding potential further development are ongoing.
Opdivo shows long-term survival results in NSCLC
Bristol-Myers Squibb Co. announced results from pooled analyses of survival data from four studies (CheckMate -017, -057, -063 and -003; n=664) in patients with previously-treated advanced non-small cell lung cancer who were treated with Opdivo (nivolumab).
In the pooled analysis of the four studies, 14% of all Opdivo-treated patients were alive at four years. Notably, in patients with PD-L1 ≥1% and <1%, four-year overall survival rates were 19% and 11%, respectively.
In the pooled analysis of the two phase III trials, CheckMate -017 and -057, the four-year OS rate for Opdivo-treated patients was 14% compared to 5% for docetaxel-treated patients. Additionally, exploratory landmark analysis of OS found that of patients who had a complete or partial response at six months, 58% of those treated with Opdivo were alive four years later vs. 12% of patients treated with docetaxel.
Of patients who had stable disease at six months, 19% of those treated with Opdivo were alive four years later vs. 2% of patients treated with docetaxel. The data were presented at the American Association for Cancer Research Annual Meeting 2019 in Atlanta.
Long-term safety data for Opdivo from all four studies were consistent with the known adverse event profile and did not reveal any new safety signals. The discontinuation rate due to treatment-related adverse events was 8.7% in patients treated with Opdivo. The most common treatment-related AE was fatigue (in 21.7% of patients).
“These analyses in a large population of patients with previously-treated advanced non-small cell lung cancer show, for the first time, that response to Opdivo correlates to a survival benefit over many years,” Scott Antonia, director of the Duke Cancer Institute Center for Cancer Immunotherapy, said in a statement. “These long-term survival outcomes are particularly interesting given that, historically, the average five-year survival rate for this patient population is approximately 5%.”
These pooled analyses were conducted to evaluate the long-term benefit (with a minimum follow-up of four years) of Opdivo and impact of response or disease control on subsequent long-term overall survival.
The pooled analysis of CheckMate -017 and CheckMate -057 represents the longest follow-up from phase 3 randomized trials of previously treated advanced non-small cell lung cancer patients treated with Immuno-Oncology therapy.
OS was estimated for patients with NSCLC across histologies treated with Opdivo in pooled analyses from CheckMate -017, -057, -063, and -003 (n=664), and for patients randomized to Opdivo (n=427) or docetaxel (n=427) in pooled analyses from CheckMate -017 and -057. Other analyses of CheckMate -017 and -057 included estimation of OS in patients alive at six months by response status at six months, and OS in all responders (complete or partial response) from the time of response.
Findings from ASCO TAPUR trial presented at AACR meeting
Three completed cohorts reporting findings in non-small cell lung cancer, breast, and metastatic colorectal cancer from the American Society of Clinical Oncology Inc.’s Targeted Agent and Profiling Utilization Registry study were presented in poster sessions during the American Association for Cancer Research Annual Meeting 2019.
In addition, all seven pharmaceutical companies currently participating in the TAPUR study have recently renewed their commitment to support it and provide study drugs at no cost for an additional one to three years.
TAPUR study participants are enrolled in cohorts based on their tumor type (e.g., any advanced solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma), the genomic alteration of their tumors, and the targeted drug(s) that correspond to those alterations.
Participants are enrolled in two stages and monitored for treatment response. Patient cohorts are either permanently closed after Stage I (less than two responses in 10 participants) or expanded to Stage II for further study and confirmation of a signal of drug activity.
The TAPUR study is designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about potential additional uses of these drugs outside of FDA approved indications. It provides a clinical trial opportunity for patients with advanced cancer who have genomic alterations in their tumors that can be targeted with a TAPUR study drug.
There are currently 113 TAPUR study sites in 20 states and nearly 1,400 participants who have received study therapy. The various drugs and their different targeted therapy options (some drugs are used in combination) are provided to patients at no cost by the seven pharmaceutical companies currently participating: AstraZeneca; Bayer; Bristol-Myers Squibb; Eli Lilly and Company; Genentech, a Member of the Roche Group; Merck; and Pfizer. ASCO is seeking to add relevant targeted therapies.
Based on collaborative work with the FDA and Friends of Cancer Research, ASCO lowered the age of TAPUR study eligibility in 2017 from 18 to 12 years to extend the opportunity for participation to adolescent patients with advanced cancer. Last month, the FDA finalized guidance for industry on expanding clinical trial eligibility criteria based on input from ASCO and Friends. The TAPUR study is registered on ClinicalTrials.gov (NCT 02693535).