Author: hepatitis

Long-term Carfilzomib May Be Safe, Effective In Relapsed Multiple Myeloma

Continuing carfilzomib therapy beyond its known long-term safety limits may provide additional clinical benefit to patients with relapsed multiple myeloma (MM), according to a study published the Journal of Hematology and Oncology.

Results of the ASPIRE trial demonstrated that carfilzomib, lenalidomide, and dexamethasone (KRd) significantly improved progression-free survival (PFS) and complete response (CR) rates compared with lenalidomide plus dexamethasone (Rd) alone among patients with relapsed MM. However, carfilzomib was discontinued after 18 treatment cycles due to a lack of long-term safety data and patients continued on Rd alone, leaving the benefit/risk profile of KRd to progression unknown.


Multiple Myeloma Combination Therapy

In a recent study, a combination therapy for the treatment of relapsed or refractory multiple myeloma proved to be as beneficial in routine clinical practice as it did in clinical trials used to support its approval.

Lenalidomide has demonstrated significant clinical activity against relapsed and refractory multiple. The phase III trials MM-009 and MM-010 have been used as supporting evidence for the US Food and Drug Administration approval of lenalidomide plus dexamethasone to treat patients with multiple myeloma who have received at least one prior therapy. Additionally, lenalidomide monotherapy is approved in the first-line setting for patients with multiple myeloma.

A group of German researchers at the Agaplesion Bethanien Hospital analyzed the effects of lenalidomide plus dexamethasone in 98 patients who were treated in routine clinical practice. Patients in the non-interventional study had a median age of 71 years, which was higher than the median ages of the phase III trials (64 and 63 years, respectively). A total of 47 patients in the non-interventional study received the combination therapy in the second-line setting, while 51 patients received it as a third-line or higher therapy.


Combination Therapy of Sofosbuvir and Daclatasvir- Effective for Hepatitis C Related Cirrhosis

Sofosbuvir and daclatasvir combination therapy (SOF/DCV) is safe and effective for real-world treatment of patients with liver cirrhosis associated with hepatitis C virus (HCV) genotype 4, according to a study published in Alimentary Pharmacology & Therapeutics.

The randomized, multicenter, open-label study took place in 2016 at 4 separate clinical settings in Egypt. A total of 551 patients with hepatitis C virus genotype 4 and related liver cirrhosis were included in the study; 119 (21.6%) had been previously treated and 432 (78.4%) were naive to treatment.

Patients were treated according to the recommendations set by the European Association for the Study of the Liver in 2015, completing 12-week treatment regimens with SOF 400 mg and DCV 60 mg once daily, with the addition of daily weight-based dosages of ribavirin (RBV). When RBV was contraindicated, duration of treatment was extended to 24 weeks.


Efficacy of Simeprevir, Daclatasvir, Sofosbuvir for HCV Genotype 1

Six and eight-week regimens of simeprevir, daclatasvir, and sofosbuvir proved highly effective for treatment-naive patients with hepatitis C virus (HCV) genotype 1 (GT1) and early-stage liver fibrosis or compensated cirrhosis, according to a study published in the Journal of Viral Hepatitis.

ACCORDION ( Identifier: NCT02349048) was a phase 2, open-label, multicenter study conducted at 8 sites in the United States and Canada between January 21, 2015, and May 5, 2016. Participant eligibility was based on the following criteria: confirmed chronic HCV GT1 infection with early-stage liver fibrosis or compensated cirrhosis, a body mass index of 18 kg/m2 to 35 kg/m2, plasma HCV RNA >10 000 IU/mL at screening, naive to treatment for HCV, and eligible for treatment with pegylated interferon and ribavirin. Study participants with early-stage fibrosis were given simeprevir 150 mg, daclatasvir 60 mg, and sofosbuvir 400 mg once daily for 6 weeks, and participants with compensated cirrhosis were given the same regimen for 8 weeks.

The study aimed for a sample size of 60 participants in the 6-week group and 30 in the 8-week group, but only 68 patients met the stipulated FibroSURE™ and APRI [aspartate aminotransferase to platelet ratio index] score cut-offs in the study protocol. As a result, there were 59 patients included in the 6-week group and 9 patients in the 8-week group.


ASCO Supports New Options for Metastatic Prostate Cancer

Adding docetaxel or abiraterone (Zytiga) to conventional androgen deprivation therapy (ADT) significantly improved overall survival in men with newly diagnosed metastatic noncastration-resistant prostate cancer (mnCRPC), according to a new guideline from the American Society of Clinical Oncology (ASCO).

Two of three randomized trials showed a survival advantage for the addition of docetaxel to ADT. A third trial that evaluated ADT with or without docetaxel did not demonstrate improved survival with the addition of chemotherapy. Two trials also showed that patients treated with abiraterone plus ADT lived longer than those treated with ADT alone.

“These two additional therapies can substantially change the outcome of men who have newly diagnosed metastatic disease,” guideline panel co-chair Michael J. Morris, MD, of Memorial Sloan-Kettering Cancer Center in New York City, said in a statement. “Having two standards of care allows flexibility and options — these choices and decisions can be negotiated between the patient and the doctor.”

The guideline was published online in the Journal of Clinical Oncology and the ASCO website.


FDA approved abiraterone acetate (Zytiga) in combination with prednisone for patients with metastatic high-risk castration-sensitive disease.

The first-line treatment of patients with metastatic castration-sensitive prostate cancer has undergone a significant number of changes in the last few years. Most recently, the FDA approved abiraterone acetate (Zytiga) in combination with prednisone for patients with metastatic high-risk castration-sensitive disease.

This approval of abiraterone was based on findings from the phase III LATITUDE trial. In the study, there was a 38% reduction in the risk of death with the addition of abiraterone and prednisone to androgen deprivation therapy (ADT) compared with ADT alone.

Another pivotal trial of abiraterone in prostate cancer was STAMPEDE. This trial showed that the addition of abiraterone to standard initial therapy lowered the relative risk of death by 37% and improved progression-free survival by 71% in both nonmetastatic and metastatic patients with high-risk hormone-naïve disease.

Although there is much excitement with androgen receptor (AR)-directed agents, docetaxel remains a staple of treatment. James Luke Godwin, MD, says that clinicians have now reached an interesting decision point on how to treat their patients in the frontline setting moving forward.


Anticancer Agent LENVIMA Approved for Additional Indication of Unresectable Hepatocellular Carcinoma (HCC) in Japan

This is the first approval worldwide for LENVIMA for the indication of unresectable HCC and the first new systemic therapy to be approved in Japan for the front-line treatment of HCC in approximately 10 years. Additionally, this is the first regulatory approval for LENVIMA under the global strategic collaboration agreement executed in March 2018 between Eisai and Merck & Co., Inc., Kenilworth N.J., U.S.A. for the co-development and co-commercialization of LENVIMA*.

Tasigna approved for children with rare form of leukemia

Novartis announced the FDA has expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.

In the U.S., Tasigna is now indicated for the treatment of adult and pediatric patients one year of age or older with newly diagnosed Ph+ CML-CP. Tasigna is also indicated for the treatment of pediatric patients one year of age or older with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor therapy, as well as adult patients with Ph+ CML in chronic phase and accelerated phase, resistant or intolerant to prior therapy that included imatinib.

This approval is the latest in a series of regulatory milestones that broadens the understanding and clinical use of Tasigna.

CML is a type of blood cancer where the body produces malignant white blood cells. Almost all patients with CML have an abnormality known as the “Philadelphia chromosome,” which produces a protein called BCR-ABL. This protein aids the proliferation of malignant white blood cells in affected patients. Worldwide, CML accounts for approximately 3% of newly diagnosed childhood leukemia.