Spectrum Pharma Fully Enrolls 1St Cohort In Poziotinib Study

Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) announced that it has rapidly completed enrollment in the EGFR cohort for previously treated non-small cell lung cancer (NSCLC) patients with exon 20 insertion mutations.

Shares of Spectrum were up almost 5.5% following this news on Wednesday. However, the Spectrum stock has tanked 49.3% in the past year, wider than the industry’s decline of 20.6%.

The open-label phase II study, which is part of the ZENITH20 program, is evaluating poziotinib, in NSCLC patients with EGFR or HER2 exon 20 mutations. Top-line data from this cohort is expected by the second half of 2019.

The EGFR previously-treated arm is the first to finish off full enrollment in the phase II ZENITH20 study on poziotinib. The primary endpoint of the study is to assess the objective response rate (ORR). Spectrum believes that the full enrollment of the first cohort is vital as data from this cohort will support the new drug application (NDA) filling for the candidate.

This study has four cohorts, two in previously treated NSCLC settings and two in first-line settings which were added to the study only last September.

We remind investors that in December 2018, the FDA did not grant a breakthrough therapy designation to poziotinib for treating metastatic NSCLC with EGFR exon 20 mutations. The decision was based on subset of outcomes from the ongoing phase II analysis at MD Anderson. Shares of Spectrum dropped significantly back then.

Poziotinib is also being evaluated in multiple mid-stage studies for addressing gastric and breast cancer as well.

Apart from poziotinib, Spectrum’s pipeline includes two late stage candidates — Rolontis and Qapzola — which are being developed for the treatment of breast cancer and bladder cancer, respectively.

Notably, last week, Spectrum submitted a biologics license application (BLA) to the FDA for getting Rolontis approved pertaining to the treatment of chemotherapy-induced neutropenia in patients with breast cancer.

The BLA was based on positive results from two phase III studies wherein Rolontis demonstrated non-inferiority to Amgen’s (NASDAQ:AMGN) Neulasta in improving duration of severe neutropenia.

Zacks Rank & Stocks to Consider

Spectrum currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include BioSpecifics Technologies Corp (NASDAQ:BSTC) and Hikma Pharmaceuticals Plc HKMPF, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BioSpecifics’ earnings estimates have been revised 16.8% upward for 2019 over the past 60 days. The stock has rallied 37% in the past year.

Hikma’s earnings estimates have moved 14.8% north for 2019 over the past 60 days. The stock has surged 41.4% in a year.

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