Spectrum Pharmaceuticals SPPI Stock News

Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) is running for the top in the market this morning, and for good reason. The company announced positive data from a Phase 2 clinical trial assessing a cancer therapy. Here’s what’s going on:

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SPPI Rockets On Positive Data

In the press release issued early this morning, Spectrum Pharmaceuticals announced that it has met its primary endpoint in a Phase 2 clinical trial. The trial, known as ZENITH20, was designed to evaluate poziotinib in previously treated non-small cell lung cancer patients with HER2 exon 20 insertion mutations.

In the release, SPPI said that the trial enrolled 90 patients who received an oral, once-daily dose of 16mg poziotinib. All patients involved in the study had previoulsy failed at least one line of prior systemic therapy with 67% of patients failing two or more lines.

Importantly, all responses in the trial were read independently and confirmed by a central imaging laboratory. Overall, the objective response rate in this patient population was 27.8%.

The company said that the median duration of response was 5.1 months, with a median follow up of 8.3 months. Also, the disease control rate came in at 70% and the median progression free survival was 5.5 months.

Froma  safety standpoint, things went overwhelmingly well. In fact, the safety profile was in line with other second-generation EGFR tyrosine kinase inhibitors and similar to cohort 1.

In a statement, Joe Turgeon, President and CEO at SPPI, had the following to offer:

The positive results of Cohort 2 are a significant milestone and we are looking forward to meeting with the FDA. We believe that poziotinib is a significant advancement for patients with this deadly disease in an area of high unmet medical need.

The above statement was followed up by Francois Lebel, M.D., CMO at SPPI. Here’s what he had to say:

We are pleased with the results of Cohort 2. There are currently no approved therapies for HER2 patients with exon 20 insertion mutations in NSCLC and we are looking forward to reviewing this data with the FDA to determine the path forward.

Final Thoughts

The news issued by Spectrum Pharmaceuticals proved to be overwhelmingly positive. First and foremost, positive clinical data in any stage brings the company one step closer to potential commercialization. As such, the data is setting the stage for further catalysts ahead.

Beyond that, the patient population being addressed in this trial was incredibly sick with most experiencing multiple prior therapies to no avail. To generate a response this strong in a sick patient population like this one is overwhelmingly difficult and acts as a feather in the cap for SPPI.

All in all, with the positive data in among very sick patients in a large target market suggests that the treatment could be better than the current standard of care. That’s overwhelmingly positive and sets SPPI stock up as one that could generate serious returns ahead.

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