First line immunotherapy for melanoma! The total remission rate of BMS / nektar star combination nktr-214 + opdivo is 53%, and the complete remission rate is 34%!

November 13, 2019 / bioun / -- nektar therapeutics, a partner of Bristol Myers Squibb (BMS), recently announced at the annual meeting of the society for cancer immunotherapy (SITC) in 2019 that bempegal desleukin (bempeg, nktr-214) and opdivo (odivo, common name: nivolumab, navumab) combined immunotherapy in the phase I / II pivot-02 study was the first-line treatment of metastasis (phase IV) Latest data of melanoma patients The data as of September 25, 2019 showed that: (1) the median follow-up period was 18.6 months Among the patients with evaluable efficacy (n = 38), the confirmed objective response rate (ORR) was 53% (20 / 38) and the complete response rate (CR) was 34% (13 / 38) In 42% (16 / 38) patients, the maximum reduction was 100% The disease control rate (DCR: complete remission + partial remission + stable disease) was 74% (28 / 38) (2) The median time of remission was 2.0 months, and the median time of complete remission was 7.9 months (3) The median reduction of lesions to baseline was 61.5% (4) At the median follow-up of 18.6 months, the median duration of remission (DOR) was not reached, and 85% (17 / 20) of the patients continued to have remission (5) In 35 patients with known baseline PD-L1 status, Orr was 39% (5 / 13) in PD-L1 negative patients and 64% (14 / 22) in PD-L1 positive patients (6) The median progression free survival (PFS) was not reached (95% CI: 5.3-ne) (6) The combination of bempeg + opdivo is well tolerated and treatment-related adverse events are predictable and transient In August 2019, BMS and nektar therapeutics announced that the U.S FDA has granted bempeg + opdivo combination therapy breakthrough drug qualification (BTD) to treat patients with previously untreated non resectable or metastatic melanoma At present, the phase III study (nct03635983) to evaluate bempeg + opdivo combination and opdivo first-line treatment for patients with advanced melanoma is recruiting patients In September 2016, Bristol Myers Squibb entered into clinical cooperation with nektar to evaluate the combination therapy of opdivo / nktr-214 for the treatment of various types of cancer In February 2018, the two sides reached another global strategic development and commercialization cooperation with a total amount of US $3.6 billion, jointly developing the joint application of nktr-214, opdivo and opdivo + yevoy in more than 20 indications of 9 tumor types, as well as the combination of other anti-cancer drugs from two companies or third parties At present, nktr-214 / opdivo immune combination therapy for melanoma and renal cell carcinoma (RCC) has entered phase III clinical Bempegaldesleukin (nktr-214) can stimulate the proliferation of anti-cancer immune cells Nktr-214 is a CD122 biased IL-2 pathway agonist, which can stimulate the proliferation of these anti-cancer immune cells in vivo by targeting CD122 specific receptors on the surface of natural killer cells, CD4 + T cells and CD8 + T cells CD122, also known as interleukin-2 receptor beta subunit, is an important signal receptor, known to increase the proliferation of these effector T cells In preclinical and clinical studies, nktr-214 treatment resulted in rapid expansion of these cells and mobilization into the tumor microenvironment Opdivo is a PD-1 immunosuppressive checkpoint inhibitor designed to overcome immunosuppression; nktr-214 is an immunostimulatory therapy that has been shown to increase tumor infiltrating cells, T-cell clones, and PD-1 expression Opdivo and nktr-214 have two different and complementary mechanisms of action; the combination of the two can improve the immune system's ability to fight cancer, which has been proved to be able to change the baseline tumor from PD-L1 negative (< 1%) to PD-L1 positive (≥ 1%) It is important to increase the number of tumor infiltrating lymphocytes (TILs) in the body to supplement the immune system, because many patients are unable to benefit from the currently approved immunosuppressive checkpoint inhibitors due to the lack of sufficient TILs cell population in the body The combination of immunosuppressant and T cell proliferation can produce synergistic effect, thus providing a new treatment option for patients Original source: 1 Near therapeutics presentations new clinical and preclinical data from its immunology pipeline at the 2019 Society for immunology of cancer (SITC) annual meeting 2 Clinical activity of bempeg plus nivo in previously untrained patients with metadata: updated results from the phase 1 / 2 pivot-02 study