Mirati Therapeutics Presents Updated Positive Clinical Data From Sitravatinib Immuno-Oncology Combination Trial At ESMO 2018 Congress And Announces FDA Guidance For Registration Trial
Highlights from the Proffered Paper Sessions (Oral Presentations) at
An ongoing Phase 2 study is evaluating the efficacy and safety of sitravatinib in combination with OPDIVO® (nivolumab), an anti-PD-1 immune checkpoint inhibitor, in patients with NSCLC who have experienced documented disease progression following prior treatment with an immune checkpoint inhibitor. As of the data cutoff date of
- 56 patients were evaluable for response with at least one radiographic scan. Patients had a median of two lines of previous therapy.
- 45/56 of evaluable patients demonstrated tumor reductions.
- 18/56 of evaluable patients demonstrated tumor reductions of greater than 30%.
- 16/56 of evaluable patients achieved a Partial Response (PR) or Complete Response (CR).
- 9 confirmed PRs or CRs.
- 2 unconfirmed PRs or CRs that remain on trial awaiting confirmation.
- 5 unconfirmed PRs or CRs that will not be confirmed.
- 26/56 evaluable patients remained on treatment at the time of data cut-off including 8 responding patients.
- A preliminary Kaplan-Meier estimate of median duration of response was greater than 9 months.
- 6 responding patients have been treated for more than 6 months.
- 2 responding patients have been treated for more than 12 months.
- The combination has been well-tolerated and most adverse events (AEs) were Grade 1 or 2.
"To date, the combination of sitravatinib and nivolumab has demonstrated a significant number of durable responses in patients with advanced NSCLC who experienced disease progression following prior checkpoint inhibitor therapy, which is one of the most challenging clinical scenarios that we currently face for this patient population," said
Sitravatinib Registration Plans
The Company also provided an update on the regulatory pathway for sitravatinib in checkpoint refractory NSCLC patients following a successful end of phase 2 meeting with the
- The trial will include an interim analysis of overall response rate (ORR) as a surrogate endpoint to serve as the basis for potential Subpart H accelerated approval. This interim analysis and the use of a docetaxel control arm follows clear guidance from the
- The primary endpoint of the final analysis for the Phase 3 clinical trial will be overall survival.
- The trial will enroll patients with NSCLC whose tumors have progressed following treatment with a checkpoint inhibitor and platinum-based chemotherapy.
- Patients will be randomized for treatment with either the combination of sitravatinib with a checkpoint inhibitor or single-agent docetaxel.
- The Company plans to initiate the pivotal Phase 3 in the first half of 2019. Ultimately, the Company expects this trial to enable a new drug application (NDA) for the treatment of NSCLC patients whose tumors have progressed following treatment with a platinum containing regimen and a checkpoint inhibitor.
"There are limited treatment options for NSCLC patients whose tumors progress following checkpoint inhibitor therapy," said
Investor Call and Webcast Information
After the oral presentation, Mirati will host a live conference call and webcast, led by Dr.
The call will also be webcast live through the "Investors" section of the Mirati corporate website at http://ir.mirati.com/events-and-presentations. A replay of the webcast will be available on the Mirati website shortly after the conclusion of the event.
Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO®), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib's potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.
Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL kinase. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release regarding the business of
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Investor and Media Relations Contact: Temre Johnson, Mirati Therapeutics Inc., Director, Investor Relations & Corporate Communications, (858) 332-3562, firstname.lastname@example.org