Lilly Announces Results from MONARCH 1 Trial of Abemaciclib Monotherapy

Excerpt:

“Eli Lilly and Company (LLY) today announced results from the MONARCH 1 Phase 2 study of abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The data, which were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting by Maura Dickler, M.D., of Memorial Sloan Kettering Cancer Center, showed that single-agent activity was observed in metastatic breast cancer patients, for whom endocrine therapy was no longer a suitable treatment option. The MONARCH 1 results (abstract #510) confirmed objective response (ORR), durability of response (DoR), clinical benefit rate (CBR) and progression-free survival (PFS).

“The single-arm study, designed to evaluate the safety and efficacy of abemaciclib monotherapy, enrolled 132 patients who were given 200 mg of abemaciclib orally every 12 hours until disease progression. Patients enrolled in the study were heavily pretreated, having experienced progressive disease on or after prior endocrine therapy, and had received prior chemotherapy with one or two chemotherapy regimens for metastatic disease. The primary objective of the trial was investigator-assessed ORR, with secondary endpoints of DoR, CBR and PFS.”

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Blinatumomab Receives Breakthrough Therapy Designation for ALL

“The FDA has granted a breakthrough therapy designation to blinatumomab for the treatment of adult patients with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), according to Amgen, the company developing the drug.

“The breakthrough therapy designation was based on results from a phase II trial of 189 patients. As of January 2014, 43% (n = 82) of patients achieved a complete remission (CR) or CR with partial hematological recovery (CRh). These results were presented at the 2014 ASCO Annual Meeting and at the 19th Congress of the European Hematology Association.

” ‘There is a high unmet need for new medicines to treat relapsed and refractory ALL patients, who have very few treatment options,’ Sean E. Harper, MD, executive vice president, Research and Development, Amgen, said in a statement. ‘The results from the phase II trial evaluating blinatumomab in adult patients with relapsed or refractory ALL are encouraging and provide a strong basis for a regulatory filing later this year and potential approval in this serious disease.’ ”

Editor’s note: Blinatumomab is a new drug that is being tested as a potential treatment for people with acute lymphoblastic leukemia (ALL) that is resistant to treatment (refractory) or that has returned after treatment (relapsed). Based on promising research results, blinatumomab has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), specifically for adults with relapsed or refractory B-precursor ALL that is Philadelphia-negative. This means that the FDA finds the drug to be very promising compared to currently available treatments, and will accelerate the approval process that would ultimately permit U.S. oncologists to prescribe the drug outside of a clinical trial.


Basilea Announces Start of Phase 2a Study with Oncology Drug Candidate BAL101553

“Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that it initiated a phase 2a study with its investigational oncology drug BAL101553. The study is designed to further characterize safety and tolerability, and to obtain efficacy data in adult patients with advanced or recurrent solid tumors who have failed standard therapy or for whom no effective standard therapy is available. Tumor types were selected based on clinical observations in the phase 1 study and a detailed analysis of potential patient stratification biomarkers across tumor indications. The study will also continue the extensive biomarker testing initiated in Phase 1, to further evaluate dose and patient populations most likely to respond.”

Editor’s note: A drug company is starting a clinical trial to test a new cancer drug called BAL101553 in volunteer patients. The trial is enrolling people with advanced or recurrent solid tumors, including people with colorectal cancer, gastric cancer or cancers of the gastro-esophageal junction, non-small cell lung cancer (NSCLC), ovarian cancer (or primary peritoneal), pancreatic cancer (including ampullary), and triple-negative breast cancer. Specifically, the trial is open to patients who have tried a standard treatment without benefitting or who, for whatever reason, have no effective standard treatment available to them. BAL101553 has already shown promise for some patients in a phase I trial. The new trial will continue to examine the safety and effectiveness of the drug, and it will also test patients’ tumors for specific biomarker molecules to see if patients with certain biomarkers are more likely to benefit.


Phase II Study Suggests Benefit of Adding Rituximab to Chlorambucil in First-Line Treatment for Chronic Lymphocytic Leukemia

“In a UK phase II study reported in the Journal of Clinical Oncology, Hillmen et al assessed the safety and activity of adding rituximab (Rituxan) to chlorambucil (Leukeran) in first-line treatment of chronic lymphocytic leukemia (CLL). Such a regimen may be an alternative to fludarabine-based treatment or chlorambucil monotherapy in elderly patients and those with comorbidities.

“In the study, 100 patients in 12 UK centers received first-line rituximab (375 mg/m2 on day 1 of cycle 1 and 500 mg/m2 thereafter) plus chlorambucil (10 mg/m2 on days 1–7) for six 28-day cycles. Patients responding but not achieving complete response could receive an additional six cycles of chlorambucil alone.

“Patients had a median age of 70 years (range, 43–86 years) and a median of seven comorbidities, 66% were male, 56% had Binet stage C disease, 36% had IgVH mutation, and 13q deletion, 12q trisomy, 11q deletion, and 17p deletion were present in 43%, 16%, 13%, and 3%, respectively.”

Editor’s note: A new clinical trial with volunteer patients tested a treatment that combines the drug chlorambucil (Leukeran) with the drug rituximab (Rituxan). The treatment was found to be safe, and may be more effective than treatment with chlorambucil alone. This combination treatment might be a good option for people with chronic lymphocytic leukemia (CLL) who might not be able to take fludarabine-based treatment, especially elderly patients and patients with comorbidities (two or more diseases).


Karyopharm Announces Initiation of Phase 2 Study of Selinexor (KPT-330) in Patients with Hormone Refractory Prostate Cancer (SHIP Study)

“Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced the initiation of a Phase 2 trial of its novel, oral Selective Inhibitor of Nuclear Export (SINE) compound Selinexor (KPT-330) in patients with metastatic hormone-refractory prostate cancer (HRPC). The study, referred to as the SHIP (Selinexor in Hormone Refractory Indications in Prostate Cancer) study, is led by Drs. Christopher J. Logothetis and John Araujo of the M.D. Anderson Cancer Center at the University of Texas in Houston and is being funded in part by a grant from the Prostate Cancer Foundation.”

Editor’s note: This story describes a new clinical trial to test a prostate cancer treatment in volunteer patients. The new drug is called Selinexor (aka KPT-330), and it may benefit patients who have been diagnosed with metastatic hormone-refractory prostate cancer.


Two Array-Invented MEK Inhibitors Showcased At ASCO

“Two Array BioPharma-invented MEK inhibitors, binimetinib (MEK162) and selumetinib, were showcased at the 50th annual meeting of the American Society of Clinical Oncology (ASCO).  At the meeting, preliminary data for the combination of binimetinib and CDK4/6 inhibitor LEE011 (discovered by Novartis Institutes for BioMedical Research in collaboration with Astex Pharmaceuticals) from a Phase 1b/2 dose-escalation study conducted by Novartis in NRAS-mutant melanoma indicates the combination demonstrated an acceptable safety profile for most patients with promising preliminary antitumor activity.  Additionally, preliminary data for selumetinib showed favorable clinical activity in pediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PNs).”

Editor’s note: This article discusses a melanoma treatment that combines two durgs: binimetinib (aka MEK162) and selumetinib. A clinical trial recently found that the combo shows promise for melanoma patients whose tumors have mutations in the NRAS gene, as detected by molecular testing. Binimetinib is also being tested as a potential treatment for patients whose tumors have mutations in the BRAF gene.


ARIAD Presents Updated Phase 1/2 Data on AP26113 in Patients with ALK+ Non-Small Cell Lung Cancer

“ARIAD Pharmaceuticals, Inc. today announced updated clinical results on its investigational tyrosine kinase inhibitor (TKI), AP26113, in patients with advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. These study results show anti-tumor activity of AP26113 in patients with crizotinib-resistant anaplastic lymphoma kinase (ALK) positive NSCLC, including patients with brain metastases. Crizotinib is approved for ALK-positive NSCLC patients.”

Editor’s note: This story is about a targeted drug called AP26113, which may benefit some patients with advanced non-small cell lung cancer (NSCLC). Specifically, it has shown promise for patients whose tumors have mutations in the ALK gene, as detected by molecular testing, and who have already been treated with the drug crizotinib (Xalkori) but have grown resistant to it.


Palbociclib Plus Letrozole Extended PFS in Metastatic Breast Cancer

“The addition of palbociclib to letrozole during first-line treatment significantly extended PFS in post-menopausal patients with ER-positive, HER-2–negative advanced breast cancer, according to final results of a randomized, open-label, phase 2 trial presented at the American Association for Cancer Research annual meeting.

“Palbociclib (PD-0332991, Pfizer), an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, prevents DNA synthesis by blocking cell cycle progression. Results of preclinical studies showed HR-positive breast cancer cells are dependent on CDK-4/6 for growth, and a phase 1 study showed the combination of palbociclib and the antiestrogen drug letrozole appeared to be a safe, effective combination.”

Editor’s note: “PFS” stands for “progression-free survival.” It refers to a period of time in which a cancer patient does not experience worsening of his/her disease. In the clinical trial described here, a combination of two drugs —palbociclib and letrozole—extended PFS for some people with ER-positive, HER-2-negative advanced breast cancer.


Phase II Trial of Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab Followed by Cetuximab and Bevacizumab in Advanced Nonsquamous Non-Small-Cell Lung Cancer: SWOG S0536

Cetuximab and bevacizumab have each been demonstrated to prolong survival when added to chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). However, the potential benefit of combining cetuximab and bevacizumab together with a platinum-based doublet had not been explored. We designed this phase II trial to evaluate the safety, tolerability, and efficacy of the combination of carboplatin, paclitaxel, cetuximab, and bevacizumab in chemotherapy-naive patients with advanced, nonsquamous NSCLC.

 

This regimen was safe, feasible, and effective as a frontline treatment of advanced NSCLC, providing the basis for the ongoing phase III trial S0819.