CDK4/6 Inhibitor Shows Promise as Single Agent in HR+ Breast Cancer


“As a single agent, abemaciclib has shown exciting potential in heavily pretreated patients with refractory, hormone-receptor (HR)–positive, HER2-negative advanced breast cancer, following phase II findings of the MONARCH 1 trial.

“Results of the single-arm study, which were presented during the 2016 ASCO Annual Meeting1, show that the CDK4/6 inhibitor induced a response rate of nearly 20% in this patient population. The median progression-free survival (PFS) was 6 months (95% CI 4.2-7.5) and the median overall survival (OS) was 17.7 months (95% CI, 16 to not reached). Previously, abemaciclib received a breakthrough therapy designation in this setting from the FDA in October 2015.”

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Investigational CDK4/6 Inhibitor Abemaciclib is Active Against a Range of Cancer Types


“The investigational anticancer therapeutic abemaciclib, which targets CDK4 and CDK6, showed durable clinical activity when given as continuous single-agent therapy to patients with a variety of cancer types, including breast cancer, non–small cell lung cancer (NSCLC), glioblastoma, and melanoma, according to results from a phase I clinical trial published in Cancer Discovery, a journal of the American Association for Cancer Research.

“The results of the trial supported the U.S. Food and Drug Administration (FDA) decision to grant breakthrough therapy designation to abemaciclib (previously known as LY2835219) for patients with refractory hormone receptor–positive advanced or metastatic breast cancer, according to one of the senior authors of the study, Amita Patnaik, MD, associate director of clinical research at South Texas Accelerated Research Therapeutics in San Antonio, Texas.”

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Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib – a CDK 4 and 6 Inhibitor – in Advanced Breast Cancer

“Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.”

The New Drug Alisertib Performs Well in a Phase I Trial

“In a phase II study reported in The Lancet Oncology, Melichar et al found that the oral aurora kinase A inhibitor alisertib was active in solid tumors, particularly breast cancer and small cell lung cancer. Aurora kinases play central roles in mitosis. Inhibition of aurora kinase A, which is overexpressed/amplified in several tumor types and associated with poorer outcome, results in abnormal spindle formation, mitotic defects, and cell death.

“In the five-arm study, patients with disease that had relapsed or was refractory to chemotherapy and who had received up to two previous cytotoxic regimens (up to four for breast cancer), not including adjuvant or neoadjuvant treatment, were enrolled from 40 centers in the Czech Republic, France, Poland, and the United States between February 2010 and May 2013. Patients received alisertib at 50 mg twice daily for 7 days followed by 14 days off in 21-day cycles. Objective response was the primary endpoint.

“Among response-assessable patients, objective response (all partial responses) was observed in 9 (18%, 95% confidence interval [CI] = 9%–32%) of 49 women with breast cancer, 10 (21%, 95% CI = 10%–35%) of 48 patients with small cell lung cancer, 1 (4%, 95% CI = 0%–22%) of 23 with non–small cell lung cancer, 4 (9%, 95% CI = 2%–21%) of 45 with head and neck squamous cell carcinoma, and 4 (9%, 95% CI = 2%-20%) of 47 with gastroesophageal adenocarcinoma.”

Early Access Program to Make ThermoDox Available in Europe for Patients with Recurrent Chest Wall Breast Cancer

The gist: Patients with recurrent chest wall (RCW) breast cancer in the European Union and Switzerland will now have access to a new treatment called ThermoDox. ThermoDox is a new way of delivering the chemotherapy drug doxorubicin. ThermoDox is spread throughout the body by the bloodstream, but it is not activated unless a doctor heats a body part to 39.5 – 42 degrees Celsius. That way, the patient can have the drug activated only to the part of the body where it is needed. Based on promising results in patients in clinical trials, ThermoDox will now be available in Europe in an Early Access Program.

“Celsion Corporation (NASDAQ:CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments,  today announced that it has signed a license and distribution agreement with myTomorrows to implement an Early Access Program for ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin, in all countries of the European Union (EU) territory plus Switzerland for the treatment of patients with recurrent chest wall (RCW) breast cancer.

“RCW breast cancer is difficult to treat and has a poor prognosis with a significant impact on a patient’s quality of life.  Patients with highly resistant tumors found on the chest wall often see their cancer progress despite previous treatment attempts including chemotherapy, radiation therapy and hormone therapy.  There are approximately 25,000 to 35,000 incidence of RCW breast cancer in the EU alone and thermal therapy is a well-accepted strategy for treating patients.  Recent findings from two Phase I studies and an ongoing open label Phase II study indicate that when combined with thermal therapy, ThermoDox can demonstrate significant overall response rates and tumor control in post mastectomy, refractory patients.”

Amrubicin Edges Topotecan for Survival in Refractory SCLC

“Amrubicin failed to improve survival over topotecan as second-line therapy for patients with sensitive small-cell lung cancer (SCLC), according to results of a new randomized phase III trial. There was, however, a small overall survival benefit seen in patients with refractory disease.

“ ‘SCLC is the most aggressive type of lung cancer,’ wrote researchers led by Joachim von Pawel, MD, of Asklepios Fachkliniken München-Gauting in Germany. ‘Despite encouraging phase II results for many targeted therapies and newer chemotherapeutic agents, current large phase III trials have failed to show improvement compared with standard of care.’ Currently, topotecan is the only approved drug for second-line therapy in SCLC patients sensitive to initial treatment; earlier work suggested the third-generation anthracycline and topoisomerase II inhibitor amrubicin could have strong activity in these patients.

“The new study included 637 patients with refractory or sensitive SCLC, assigned 2:1 to amrubicin or topotecan. The median overall survival was 7.5 months with amrubicin and 7.8 months with topotecan, for a hazard ratio of 0.880 (95% CI, 0.733-1.057; P = .170).”

Updated: New Melanoma Drug Shows Promise In Trial, But Questions About Effectiveness Remain

The gist: Earlier this month we posted about promising results from a clinical trial testing a new treatment called PV-10. Now, an oncologist who was not involved in the research has told a Forbes reporter that the results may not be as promising as they sound.

“A new cancer drug benefited 51% of stage III and IV melanoma patients during a phase II trial, achieving complete response (total cancer disappearance) in 26% during the treatment period. That was all in just 16 weeks of treatment, and would seem to suggest this drug, being developed by a small company ignored by Wall Street, has potential for treating certain cancers in the future.

“But an independent oncologist not associated with the trial says that the results may not be so impressive after all, based on the data from the published study.

John Glaspy, an oncology professor at UCLA, says that ‘it’s not clear’ whether the result are important. If they are talking about lesions that were not directly injected with the drug, the results would be meaningful. ‘If they are talking about the injected lesion, not so much,’ Glaspy says.

“When asked about it, he repeated: ‘Like I said, these SQ melanomas are an indolent disease, and it is not a big deal if you inject them and they regress.  I don’t think you have any evidence that anybody is cured.’ “

PV-10 Well-Tolerated in Treatment of Refractory Cutaneous Melanoma

The gist: A new treatment has shown early promise for treating people with cutaneous melanoma that worsened after previous treatment. The new treatment involves injecting a substance called rose bengal disodium into melanoma lesions. It was tested in volunteer patients in a recent clinical trial. The treatment proved safe, and 51% of the patients experienced a good response.

“Intralesional injection of rose bengal disodium was well-tolerated in patients with refractory cutaneous melanoma, with just over half of patients meeting the primary study endpoint, according to a poster presented at the European Society of Medical Oncology Annual Congress.

“Researchers included 80 patients with 6.3-cm median sum lesion diameter in biopsy-confirmed melanoma that was refractory to a median of six previous interventions in the study. The patients received intralesional injections of rose bengal disodium (PV-10) in up to 20 cutaneous and subcutaneous lesions up to four times during a 16-week period. Follow-up was 52 weeks.

“The researchers assessed best overall response rate (BORR) in up to 10 injected target lesions, and secondary endpoints included the assessment of response duration, BORR of untreated bystander lesions, overall survival and adverse events.

“PV-10 was found to be well-tolerated, and 41 patients achieved the study’s primary endpoint of an objective response for an overall response rate of 51%.”

Novel Cancer Drug Proves Safe for Leukemia Patients

The gist: Scientists tested a new leukemia drug in a clinical trial—a research study with volunteer patients. The drug is called CPI-613. In the trial, it was found to be safe and effective for people with leukemia that is relapsed (returned after treatment) or refractory (doesn’t respond to treatment). More research will be performed to better understand how well the drug works.

“Results of a Phase I clinical trial showed that a new drug targeting mitochondrial function in human cancer cells was safe and showed some efficacy. The findings, reported by doctors at Wake Forest Baptist Medical Center, are published in the current online edition of the journal Clinical Cancer Research.

” ‘This drug is selectively taken up by cancer cells and then shuts down the production of energy in the mitochondria,’ said Timothy Pardee, M.D., Ph.D., director of leukemia translational research at Wake Forest Baptist and principal investigator of the trial. ‘This is the first drug to inhibit mitochondria in this way and if it proves effective in further clinical trials, it will open up a whole new approach to fighting cancer.’ “