Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Poziotinib Into First-Line Therapy and Doses First Patient!

Oh boy, it's what we've been patiently tapping our feet for. I've been mumbling to myself Come-on Spectrum get this first-line show on the road so that next year we'll have info available for the Conferences and PRs and the sooner we'll get approval in an expanded patient population. And just as importantly, will be used off-label in first-line when approved in second-line and interim data in first-line assuming it 'meets expectations'. And just as important, they are executing on their action plan. No delays like occurred w Rolontis and their 2016 timeline.

We learned some interesting new info from the PR

- SPPIs first-line trial will be in 70 pts each instead of 87 in second-line. Left unsaid is that in second-line they'll probably stop at 70 pts.
- For the SPPI study they are using someone from outside of SPPI to talk about the study "Jonathan Goldman, M.D., Associate Professor of Hematology and Oncology, Associate Director of Drug Development and Director of Clinical Trials in Thoracic Oncology at UCLA Health"
- Left unsaid is what's going on w MDAs trial cohorts in first-line. Are they going to run it? Do they need to run it? Probably not.
- And this was interesting, independent cohorts, meaning that each cohort is like a stand alone trial so you know that each cohort will look to get BTD independently w second-line EGFR coming up to bat first.

Sep 12, 2018
Spectrum Pharmaceuticals Expands Poziotinib Clinical Trial Into First-Line Therapy and Doses First Patient

Spectrum’s Phase 2 non-small cell lung cancer (NSCLC) study expanded to include two new cohorts for first-line NSCLC patients with EGFR or HER2 exon 20 insertion mutations

Phase 2 study now includes four cohorts with each cohort being an independent study with pre-specified statistical hypotheses and statistical power

First patient has been dosed in this expanded patient population

HENDERSON, Nev.--(BUSINESS WIRE)--Sep. 12, 2018-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that it has initiated two new cohorts for first-line, locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR or HER2 exon 20 insertion mutations in its current Phase 2 non-small cell lung cancer (NSCLC) clinical trial. Spectrum also announced that it has dosed the first patient in the expanded patient population.

“Given the exciting preliminary poziotinib clinical data in NSCLC patients with EGFR exon 20 mutations who have received prior systemic therapy, we are happy to extend our participation in Spectrum’s trial to explore poziotinib's activity in the first-line setting,” said Jonathan Goldman, M.D., Associate Professor of Hematology and Oncology, Associate Director of Drug Development and Director of Clinical Trials in Thoracic Oncology at UCLA Health. "Current available therapies for NSCLC patients with exon 20 insertion mutations have been shown to be minimally effective. We do not have good options for these patients as we do in other settings with actionable mutations. This clinical trial expansion is a welcome milestone for patients and physicians battling this disease.”

The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 mutations currently consists of a Phase 2 pivotal, Spectrum-sponsored, multi-center global study (ZENITH20) with active sites in the United States and future centers planned in Canada and Europe, and a Phase 2 investigator-initiated study at the University of Texas MD Anderson Cancer Center. Spectrum’s ZENITH20 study now includes four cohorts, with each cohort being an independent study with pre-specified statistical hypotheses and statistical power. The protocol amendment incorporating the two new cohorts was designed based on input from the FDA. The two previously-treated cohorts will enroll up to 87 patients each, and the two first-line cohorts will enroll up to 70 patients each. For each cohort, the primary endpoint is objective response rate; the secondary endpoints are disease control rate, duration of response, safety and tolerability; and the exploratory endpoints are progression-free survival and quality of life.

About Poziotinib
Poziotinib is a novel, orally administered Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) as well as HER2 and HER4. Importantly, this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer and gastric cancer. Spectrum received an exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals.