This manuscript, entitled "Bempegaldesleukin (NKTR-214) Plus Nivolumab in Patients With Advanced Solid Tumors: Phase 1 Dose-Escalation Study of Safety, Efficacy & Immune Activation (PIVOT-02)," is published online and can be accessed here https://cancerdiscovery.aacrjournals.org/content/early/2020/05/20/2159-8290.CD-19-1510
Key findings are summarized below:
- Established the recommended Phase 2 dose (RP2D) of BEMPEG 0.006 mg/kg q3w plus nivolumab 360 mg q3w
- AEs were manageable and generally transient and reversible
- Combination of BEMPEG plus nivolumab increased absolute numbers and proliferation of CD8+ T- and NK cells in the peripheral blood, and increased expression of genes relating to immune activation in the tumor microenvironment, including the genes encoding the interferon gamma inflammatory response to PD-L1
- BEMPEG plus nivolumab demonstrated encouraging ORRs across multiple tumor types, independent of baseline PD-L1 expression. These responses continued to deepen over time
- Total ORR was 59.5%, CR was 18.9%, and DCR 83.8%
- ORR in PD-L1+ and PD-L1- patients was respectively 64.7% and 50.0%
- Among the 22 patients with confirmed objective responses, median TTR was 1.9 months (range 1.3-7.8) and median DOR was not reached
"These PIVOT-02 data further demonstrate the scientific and clinical rationale for combining BEMPEG with nivolumab for a range of advanced solid tumors. We are excited that this combination is now being developed in several ongoing Phase 2 and 3 registration trials. We look forward to the continued development of this promising combination treatment regimen," remarked Dr.
BEMPEG in combination with nivolumab is being evaluated in multiple clinical trials including metastatic melanoma (NCT03635983), muscle-invasive bladder cancer (NCT04209114), metastatic cis-ineligible urothelial cancer (NCT03785925) and metastatic renal cell carcinoma (NCT03729245).
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco,
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "may," "can," "develop," "continue," "maintain," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make concerning the therapeutic potential of bempegaldesleukin ("BEMPEG"), the maintenance and deepening of responses following the administration of BEMPEG in combination with nivolumab, and our future development plans for BEMPEG. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) the extent and duration of the impact of the COVID-19 pandemic on our business, regulatory efforts, research and development, clinical trials (including those being led by us and our partners), and corporate development activities will depend on future developments that are highly uncertain and cannot be accurately predicted, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the
Vivian Wu of Nektar Therapeutics
Dan Budwick of 1AB
1Bentebibel, S.E.; Hurwitz, M.E.; Bernatchez, C.; Haymaker, C.; Hudgens, C.W.; Kluger, H.M.; Tetzlaff, M.T.; Tagliaferri, M.A.; Zalevsky, J.; Hoch, U.; et al. A First-in-Human Study and Biomarker Analysis of NKTR-214, a Novel IL2Rbetagamma-Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors. Cancer Discov. 2019, 9, 711–721.
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