Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer

Excerpt:

“Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting. 

“The risk of disease progressed was reduced by 42 with the addition of palbociclib, a CDK4/6 inhibitor, when compared with letrozole alone. The combination of palbociclib and letrozole was granted an accelerated approval in February 2015, based on the phase II PALOMA-1 study. These results from PALOMA-2 provide confirmation of the combination’s benefits in the frontline setting.

“ ‘These data represent the longest frontline improvement in median PFS seen to date in women with advanced ER+ breast cancer,’ senior study author Dennis J. Slamon, MD, PhD, chief of the Division of Hematology/Oncology in the UCLA Department of Medicine, said when presenting the findings at ASCO.”

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Bevacizumab/Erlotinib Combo Approved in Europe for NSCLC

Excerpt:

“The European Commission approved bevacizumab (Avastin) in combination with erlotinib (Tarceva) as a frontline treatment for patients with unresectable advanced, metastatic, or recurrent EGFR-mutant non–small cell lung cancer (NSCLC).

“The approval was based on findings from the phase II JO25567 study, which showed a 46% reduction in the risk of progression or death with the combination versus single-agent erlotinib. The median progression-free survival (PFS) with the addition of bevacizumab was 16 versus 9.7 months with erlotinib alone (HR, 0.54; 95% CI, 0.36-0.79; P = .0015).

“ ‘The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,’ Sandra Horning, MD, chief medical officer and Global Head of Product Development at Roche, the company developing the combination, said in a statement. ‘This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond 1 year, representing important progress for a group of patients who typically face a poor prognosis.’ ”

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Sacituzumab Govitecan Shows Promise for Metastatic NSCLC

Excerpt:

“Treatment with sacituzumab govitecan induced objective responses and appeared tolerable in patients with metastatic non–small cell lung cancer who had received first-line platinum-based therapy, according to the results from an expansion cohort of a phase 1/2 study presented at the ASCO Annual Meeting.

” ‘This therapy showed efficacy for squamous and non-squamous patients as well as for patients with prior PD-1/PD-L1 therapy,’ D. Ross Camidge, MD, PhD, professor in the division of medical oncology and Joyce Zeff chair in lung cancer research at University of Colorado Anschutz Medical Campus, said during a presentation.

Sacituzumab govitecan (IMMU-132, Immunomedics) is an antibody drug conjugate comprised of SN-38 — the active metabolite of irinotecan, a topoisomerase inhibitor — conjugated to an anti–Trop-2 humanized monoclonal antibody.”

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Immunomedics’ Sacituzumab Govitecan (IMMU-132) Demonstrates Efficacy and Safety in Non-Small-Cell Lung Cancer Patients With Multiple Prior Treatments, Including Immuno-Oncology

Excerpt:

Immunomedics, Inc., (IMMU) today announced that sacituzumab govitecan (IMMU-132), its lead investigational antibody-drug conjugate (ADC), shrank tumors by 30% or more initially in 26% (12/46) of evaluable patients with metastatic non-small-cell lung cancer (NSCLC), with a later confirmed overall objective response rate (ORR) of 13%, in accordance with RECIST 1.1 criteria. For the patients with confirmed responses, the duration of response (DOR) was 9 months.

“Interim median progression-free survival (PFS) and overall survival (OS) were 3.9 months (95% confidence interval [CI]; 3.4, 6.9) and 10.5 months (95% CI; 5.8, 10.5), respectively. Significant tumor shrinkage and disease stabilization was observed in both adenocarcinoma and squamous cell carcinomas, the two major subtypes of NSCLC, and in patients who had failed previous anti-PD-1/PD-L1 therapy.”

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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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Total Body Irradiation Did Not Improve Response of Adoptive Cell Transfer

Excerpt:

“Adding total body irradiation to preparative lymphodepletion chemotherapy prior to the adoptive cell transfer of tumor-infiltrating lymphocytes (TILs) had no effect on tumor regression in patients with metastatic melanoma, according to the results of a study published in the Journal of Clinical Oncology.

“However, adoptive cell transfer of TILs did mediate the objective complete response of 24% of patients.

“ ‘The nonmyeloablative chemotherapy regimen thus seemed to provide sufficient lymphodepletion for successful adoptive transfer without the need to add total body irradiation,’ wrote researchers led by Stephanie L. Goff, MD, of the National Cancer Institute.”

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Distinct Features Associated With Benefit for BRAF/MEK Inhibition

Excerpt:

“With the development of novel targeted and immunotherapeutic agents that are more efficacious than traditional chemotherapy, treatment paradigms in melanoma have undergone major changes. Current recommendations for first-line systemic therapy for patients with advanced or metastatic melanoma consider BRAF mutation status, tumor growth rate, and the presence or absence of cancer-related symptoms.

“Immunotherapies with agents that block CTLA-4 or PD-1/PD-L1 checkpoints have been associated with durable responses in a subset of patients, and are often considered for patients with low-volume, asymptomatic metastatic melanoma. Targeted therapies, on the other side, are preferred for patients with BRAF-mutant tumors who have symptomatic disease and benefit from the rapid response associated with these agents.”

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Merrimack Presents Expanded Analysis from Seribantumab (MM-121) Phase 2 Breast Cancer Study at the AACR Precision Medicine Series

Excerpt:

“Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today presented an expanded analysis of its Phase 2 study of seribantumab (MM-121) in combination with exemestane in HER2-negative, hormone receptor positive metastatic breast cancer.  Top line results from this study were announced in 2014. The final analysis, as well as a poster on Merrimack’s investigational companion diagnostic for seribantumab, were presented this week at the AACR Precision Medicine Series: Targeting the Vulnerabilities of Cancer, in Miami, Florida.

” ‘This data package underscores the most significant finding from all of our seribantumab Phase 2 studies – the identification of a heregulin-positive cancer cell phenotype that infiltrates approximately 30-50% of tumors and that may directly impact response to current standard-of-care therapies.  This hypothesis is supported by a strong consistent data set that spans three solid tumor types where we saw improved progression free survival when seribantumab was added to each of the standard-of-care regimens,’ saidAkos Czibere, MD, Ph.D., Senior Medical Director and Team Lead for the seribantumab program. ‘We are currently pursuing a registration study for seribantumab in patients with non-small cell lung cancer whose disease has progressed following immunotherapy.’ ”

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Long-Term Survival Achieved in Metastatic Melanoma With Personalized Vaccine

Excerpt:

“Two patients with melanoma that had spread to the liver survived for at least 8.5 and 12 years after resection of the hepatic tumor and treatment with patient-specific immunotherapeutic vaccines. The vaccines, designed to activate the immune system against the tumor, were derived from the patients’ own dendritic cells loaded with proteins isolated from their tumors, as described in an article published in Cancer Biotherapy and Radiopharmaceuticals.

“Robert O. Dillman, MD, formerly Vice President Oncology, Caladrius Biosciences, Inc. and currently Chief Medical Officer, NeoStem Oncology (Irvine, CA) and Executive Medical and Scientific Director, Hoag Cancer Institute (Newport Beach, CA) discusses the typically poor prognosis for patients with melanoma of the eye or skin that spreads to the liver, and reports on the potential to achieve long-term survival without disease progression in a subset of patients using the eltrapuldencel-T vaccine. One patient had no disease progression for more than 4.5 years, while the other patient survived and remained disease-free for more than 12 years.”

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