Spectrum Pharmaceuticals Inc. (SPPI) shares are up 18.15% in premarket trading to $1.53 after announcing a presentation data. The stock closed Friday’s session at $1.29 up 2.78%.
What SPPI has presented?
As part of a poster presentation titled: “High Activity of Poziotinib in Non-Small Cell Lung Cancer (NSCLC) with G778_P780dup HER2 Exon 20 Insertion Mutations” Spectrum Pharmaceuticals (SPPI) has announced data. Both newly diagnosed patients with NSCLC and patients who have been previously treated with poziotinib show high responses to it.
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On September 12, 2022, Xiuning Le, M.D., Ph.D., Assistant Professor, The University of Texas MD Anderson Cancer Center, will present a poster. The poster will be available to registered participants at ESMO 2022 taking place in Paris from September 9-13.
Spectrum Pharmaceuticals Chief Medical Officer Dr. Francois Lebel said the G778 mutation is one of the most common exon 20 insertion mutations in HER2, with an adverse prognosis for patients with these tumors. Poziotinib was highly effective, both in patients who were untreated as well as those who had been heavily pretreated.
Patient results for Poziotinib
Poziotinib was evaluated for its activity in patients with Dup HER2 exon 20 insertion mutations from the ZENITH20 clinical trial, both previously treated (Cohort 2) and treatment-naive (Cohort 4). In Cohort 2 (C2), poziotinib was given once-daily (QD) and in Cohort 4 (C4), it was given twice daily (BID). This study was designed to examine the objective response rate (ORR) as the primary endpoint. There were fourteen patients with the G778 insertion mutation in HER2.
A total of 12 out of 14 patients were evaluable with partial responses, resulting in an ORR of 85.7% (95% CI, 57.2, 98.2) and a median DOR of 5.5 months (range 2.9-14.1). Patients with previous C2 treatments had a 100% ORR, while patients with new C4 treatments had a 71.4% ORR. Those in C2 had a median DOR of 5.3 months, while those in C4 had a median DOR of 8.9 months. There were similar adverse events to the class of TKIs in terms of frequency and overall.
In separate news Friday, the US Food and Drug Administration (FDA) has approved ROLVEDONTM (eflapegrastim-xnst) injection by Spectrum Pharmaceuticals (SPPI). A clinically significant incidence of febrile neutropenia has been demonstrated in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with febrile neutropenia, which can be reduced by using ROLVEDONTM (eflapegrastim-xnst) injection to decrease the risk of infection.
How this will impact SPPI?
The approval marks the company’s transition to a commercial-stage company. This approval is an important milestone for the development team at Spectrum Pharmaceuticals (SPPI) and in collaboration with Hanmi Pharmaceutical. The SPPI team wants to thank all patients, families, health care providers, as well as our own team members for helping us achieve this goal.