August 28, 2019 - Episode 1

FDA Guidelines in Male Breast Cancer, Encouraging Data in Breast Cancer and Myeloma, and More

Today- New FDA clinical trial guidelines in male breast cancer, encouraging findings in breast cancer and multiple myeloma, and European approvals in breast cancer and multiple myeloma.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA is eager to improve the treatment armamentarium for male patients with breast cancer through the issuance of industry guidelines designed to encouraging the inclusion of male patients in breast cancer clinical trials.

The industry guidelines, which are still in draft form, pertain to the development and labeling of cancer treatments regulated by the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research.

The draft recommendations state that clinical trials exploring breast cancer treatments should allow for enrollment of both men and women. When investigators wish to exclude male participants, a scientific rationale should be provided.

Additionally, for breast cancer drug trials that exclude males or have limited male enrollment, the potential should be explored to extrapolate data to include men in the FDA-approved indication for the drug where no difference in efficacy or safety is anticipated between genders based on the mechanism of action of a drug.

However, when additional data are needed to support an indication for male patients, the FDA encourages exploring various practical options to obtain the data, such as small, single-cohort studies and studies that use real-world data sources.

These draft recommendations are now publicly available, and the FDA will accept comments on them until October 26, 2019.


Also in breast cancer, the combination of pyrotinib with capecitabine led to a 64% reduction in the risk of disease progression or death versus lapatinib plus capecitabine in Chinese patients with relapsed or metastatic HER2-positive breast cancer who previously received taxanes, anthracyclines, and/or trastuzumab.

Results showed that the median progression-free survival was 18.1 months in the pyrotinib arm compared with 7.0 months in the lapatinib arm. Moreover, the overall response rates were 78.5% versus 57.1%, respectively.

The ORR in the pyrotinib arm was comprised of 3 complete responses and 48 partial responses, and 14 patients had stable disease and no patients had progressive disease. The median time to progression was 19.5 months and the median duration of response was 16.7 months.

Regarding safety, the most common grade 3/4 adverse events with pyrotinib versus lapatinib, respectively, were hand-foot syndrome, diarrhea, and decreased neutrophil count. The study authors noted that additional studies in other races will be required to confirm pyrotinib’s efficacy in these populations.


In results of the DREAMM-2 trial, the antibody-drug conjugate belantamab mafodotin met the primary endpoint of demonstrating a clinically meaningful overall response rate in patients with relapsed/refractory multiple myeloma.

Patients enrolled in the study were refractory to treatment with an anti-CD38 antibody, a proteasome inhibitor, and an immunomodulatory drug.

Full data from the study have not yet been made available. However, GlaxoSmithKline, the developer of the agent, noted in a press release that the safety and tolerability results for DREAMM-2 were similar to the findings reported in the first-in-human phase I DREAMM-1 trial.

The FDA granted belantamab mafodotin a breakthrough therapy designation in November 2017 for the treatment of patients with relapsed/refractory multiple myeloma who have failed 3 or more prior lines of therapy, including an anti-CD38 antibody, and who are refractory to a proteasome inhibitor and an IMiD agent. The agent also received PRIME designation from the European Medicines Agency.


The European Commission has approved the frontline combination of atezolizumab plus nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1—positive triple-negative breast cancer. The indication is specific to patients with a PD-L1 expression level of at least 1%.

The approval is based on data from the phase III IMpassion130 trial, in which the addition of atezolizumab to nab-paclitaxel reduced the risk of progression or death by 38% compared with nab-paclitaxel alone in this patient population.

The EC simultaneously granted marketing authorization to Roche’s VENTANA PD-L1 (SP142) Assay to identify patients with TNBC whose PD-L1 levels make them eligible for treatment with the atezolizumab/nab-paclitaxel regimen.

The FDA approved this combination in this setting of TNBC in March 2019.


In multiple myeloma, the European Commission has approved elotuzumab for use in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.

The approval is based on data from the phase II ELOQUENT-3 trial, in which the addition of elotuzumab to pomalidomide and dexamethasone reduced the risk of disease progression or death by 46% versus pomalidomide and dexamethasone alone for patients with relapsed/refractory disease.

Results showed that the median progression-free survival was 10.3 months with the elotuzumab combination compared with 4.7 months with pomalidomide plus dexamethasone. The PFS benefit associated with the triplet was similar, regardless of whether patients had received 2 to 3 prior lines of treatment or at least 4 lines of therapy. The FDA approved the elotuzumab regimen in November 2018 for this indication.


This week, we sat down with Dr Sherif S. Farag, of Indiana University Health, to discuss identifying and treating patients with CAR T-cell therapy.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.