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Spectrum Pharma Includes First-Line NSCLC in Poziotinib Study

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Spectrum Pharmaceuticals, Inc. (SPPI - Free Report) announced that it has added two new cohorts in the phase II study — ZENITH20.  The study is evaluating its pipeline candidate, poziotinib, in non-small cell lung cancer ("NSCLC") patients with EGFR or HER2 exon 20 mutations. The two new cohorts will evaluate the candidate in first-line setting.

The decision was taken based on encouraging preliminary data from the ZENITH20 study in NSCLC patients with EGFR exon 20 mutations who have received prior systemic therapy and after consulting the FDA.

Preliminary data from the first 11 patients showed that poziotinib achieved an objective response rate (“ORR”) of 64% in the phase II study. This was higher than ORR of 20-30% expected initially. Although the candidate did not reach a median progression free survival (“PFS”) after a median follow up of 6.5 months, it has displayed potential of PFS benefit in the patient population.

The data were well received by investors. In August, the company had announced that the FDA allowed the study to be viewed as a pivotal registration study, which suggests data from this data can be used for regulatory filings.

Spectrum Pharma’s stock has been up 5.5% so far this year, outperforming the industry’s 0.8% increase in the period.

Product sales of Spectrum Pharma have been on the decline for the post few quarters. Thus, successful development of its pipeline, which includes poziotinib, Qapzola and Rolontis, is necessary for the growth of the company. The addition of first-line NSCLC cohorts is a significant step as the currently available therapies have minimal effect, providing good opportunity for poziotinib upon successful development. However, it is a long way before clinical studies are concluded to get actual benefits.

Poziotinib is also being developed in other indications, which include breast and gastric cancer.

AstraZeneca (AZN - Free Report) is also developing Tagrisso (osimertinib) for treating Exon 20 mutant NSCLC, which is currently approved for NSCLC patients with EGFR T790M mutation.

Zacks Rank & Stocks to Consider

Spectrum Pharma currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the pharma sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and Catabasis Pharmaceuticals, Inc. (CATB - Free Report) . While Pacira sports a Zacks Rank #1 (Strong Buy), Catabasis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Pacira’s earnings estimates increased from 24 cents to 49 cents for 2018 and from 96 cents to $1.07 for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 172.92%. The stock has rallied 20.9% in the past three months.

Catabasis’ loss estimates narrowed from $1.04 to 75 cents for 2018 and from $1.56 to 67 cents for 2019, in the last 60 days. The company came up with a positive earnings surprise in three of the preceding four quarters, with an average beat of 7.81%.

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