Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) Q2 2020 Earnings Conference Call - Final Transcript
Aug 10, 2020 • 04:30 pm ET
Riga, our Chief Operating Officer will have more to say on this later in the call. And then finally, our CFO, Kurt Gustafson will go through the financial numbers.
Overall, I believe that Spectrum is well-positioned to drive its late-stage product development assets forward, and we have the team and the necessary financial resources in place to advance these programs. We can re-enter the commercial arena and achieve our long term goals.
And with that, I want to turn it over to Dr. Francois Lebel, our CMO for an update on our clinical development progress.
Good afternoon everyone, and thank you for being on the call today. Our recent announcement of a positive outcome for Cohort 2 of the ZENITH20 clinical trial is an important achievement for lung cancer patients with these mutations and for our Spectrum team. We are thrilled with this outcome. It is exciting progress since there is no approved treatment for patients with HER2 exon 20 insertion mutation in non-small cell lung cancer.
The ZENITH 20 Cohort 2 enrolled 90 patients and it is the largest prospective multicenter trial ever conducted in this patient population, with over 70 participating sites in the U.S., Canada, Israel and Europe. Patients received a 16 milligram once-daily oral dose of poziotinib given in a 28-day cycle. All of the patients had failed at least one line of prior systemic therapy and 60 patients had failed two or more prior therapies, including chemotherapy and immunotherapy.
The primary endpoint was objective response rate as defined by RECIST 1.1. Secondary endpoints included duration of response, progression-free survival and disease control rate. The intent-to-treat analysis demonstrated an ORR of 27.8%. The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17% with a 95% Confidence Interval. At the data cut-off, with a median follow-up of 8.3 months, the responses were durable with a median of 5.1 months with some patients continuing to receive drug after one year. Progression-free survival was 5.5 months with a disease control rate of 70%. The safety profile was in line with the type of adverse events seen with other second generation tyrosine kinase inhibitors and was similar to what we saw in Cohort 1.
We plan to present additional safety and efficacy data for Cohort 2 at an upcoming medical meeting later this year. I'll remind you that Cohort 2 was designed to be a registrational trial. We are in the process of requesting a pre-NDA meeting with the FDA based on these positive results to seek an indication for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer with HER2 exon 20 insertion mutation.
Now, let me review where we are with the additional cohorts in this trial. Topline results for both Cohort's 1 and 2 have now been reported. And we expect to report the results from Cohort 3 by the end of this year. Several months ago, we made dosing modification to the other cohorts in the ZENITH20