Poziotinib is under development for patients with non-small-cell lung cancer with a genetic mutation that involves exon 20 insertion. In 3Q17, Spectrum Pharmaceuticals (SPPI) presented preliminary data from the Phase 2 study at the world conference on lung cancer in Japan. This data showed an overall 73% response rate in patients.
Spectrum Pharmaceuticals initiated a Phase 2 study for Poziotinib and has commenced enrollment of patients in this trial. The company is also conducting a study of Poziotinib for breast cancer patients.
Spectrum Pharmaceuticals (SPPI) obtained exclusive rights to commercialize Poziotinib from Hanmi Pharmaceutical (HANPF) under an in-license agreement in 2015. SPPI is obligated to make milestone payments on regulatory and sales targets in the range of ~$33.0 million to $325.0 million.
Neratinib from Puma Biotech (PBYI) is a competing drug in the lung cancer market for Poziotinib. Neratinib received regulatory approval in July 2017 and was launched in September under the name Nerlynx. In 3Q17, Nerlynx generated revenues of $6.0 million for Puma Biotech.
Spectrum Pharmaceuticals (SPPI) expects top-line data from the ADVANCE trial, comprising more than 400 patients in the US in 1Q18. Rolontis is targeted for the chemotherapy-induced neutropenia market.
SPPI is also enrolling patients for a second trial of Rolantis. The international study, called RECOVER, encompasses the US, Europe, and Canada. The company expects to file a Biologics License Application (or BLA) in 4Q18.
Another drug candidate under development in the Chemotherapy Induced Neutropenia (or CIN) market is Plinabulin from BeyondSpring Pharmaceuticals. Currently, the drug is in its Phase 2 trial.
SPPI’s Phase 3 study for Qapzola, which is a novel tumor-activated cancer drug for bladder cancer, is in the process of enrolling patients. This study is expected to enroll ~430 patients.
Merck’s (MRK) Keytruda is a key drug in this segment. Keytruda generated revenues of ~$1.0 billion for Merck in 3Q17.
Spectrum Pharmaceuticals makes up about 0.27% of the iShares NASDAQ Biotechnology ETF’s (IBB) total portfolio holdings.
In the final part of this series, we’ll take a look at Spectrum Pharmaceuticals’ financials.