NKTR-255 is wholly owned by Nektar and is currently being evaluated in two separate clinical studies in both liquid and solid tumors. The novel IL-15 agonist is designed to activate the IL-15 pathway to expand both natural killer (NK) cells and memory CD8+ T cell populations.1 Avelumab, which is marketed in the
"We are excited to partner with Merck KGaA, Darmstadt,
Under the new collaboration, Merck KGaA, Darmstadt,
BAVENCIO® (avelumab) is indicated in the
NKTR-255 is an investigational agent in clinical development and is not approved alone or in combination with avelumab (or any other agent) for use in any country.
About Urothelial Carcinoma
Bladder cancer is the 10th most commonly diagnosed cancer worldwide, with approximately 573,000 new cases and 213,000 deaths.2 It is more common in men than in women, representing the 6th most common cancer and the 9th leading cause of cancer death among males. Incidence rates for men and women are respectively 9.5 and 2.4 per 100,000. Mortality rates for men and women are respectively 3.3 and 0.9 per 100,000.2 Noninvasive cancers reflect a large proportion of all bladder cancers2, and only 25% to 55% of patients receive any second-line therapy after first-line chemotherapy.3-9 In the
BAVENCIO Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.
NKTR-255 is a novel polyethylene glycol (PEG)-conjugate of recombinant human interleukin-15 (rhIL-15), which was designed to retain all known receptor binding interactions of the IL-15 molecule. The investigational candidate is uniquely designed to overcome known challenges of recombinant IL-15 and other IL-15 agonists, which are rapidly cleared from the body and have shown diminishing response to successive doses. Through an extended circulating half-life and optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional NK cell populations and formation of long-term CD8+ mediated immunological memory, which may lead to sustained anti-tumor immune response.
BAVENCIO is a registered trademark of Merck KGaA, Darmstadt,
- Miyazaki T, Maiti M, Hennessy M, et al. NKTR-255, a novel polymer- conjugated rhIL-15 with potent antitumor efficacy.
Journal for ImmunoTherapy of Cancer2021;9:e002024. doi:10.1136/jitc-2020-002024.
- Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660.
- Cheeseman S, et al. Current treatment and outcomes benchmark for locally advanced or metastatic urothelial cancer from a large
UK-based single centre. Front Oncol. 2020;10:167.
- Aly A, et al. Overall survival, costs, and healthcare resource use by line of therapy in Medicare patients with newly diagnosed metastatic urothelial carcinoma. J Med Econ. 2019;22:662-670.
- Galsky MD, et al. Real-world effectiveness of chemotherapy in elderly patients with metastatic bladder cancer in the United States. Bladder Cancer. 2018;4(2):227-238.
- Fisher MD, et al. Treatment patterns and outcomes in stage IV bladder cancer in a community oncology setting: 2008-2015. Clin Genitourin Cancer. 2018;16:e1171-e1179.
- Niegisch G, et al. A real-world data study to evaluate treatment patterns, clinical characteristics and survival outcomes for first- and second-line treatment in locally advanced and metastatic urothelial cancer patients in Germany. J Cancer. 2018;9(8):1337-1348.
- Flannery K, et al. Outcomes in patients with metastatic bladder cancer in the USA: a retrospective electronic medical record study. Future Oncol. 2019;15:1323-1334.
- Simeone JC, et al. Treatment patterns and overall survival in metastatic urothelial carcinoma in a real-world, US setting. Cancer Epidemiol. 2019;60:121-127.
Kantar Health. CANCERMPACT – treatment architecture. https://www.kantarhealth.com/docs/datasheets/cancermpact-treatment-architecture.pdf?sfvrsn=6&sfvrsn=6. Accessed September 2021.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "will", "may," "design," "potential," "provide," "expect," "indicate," "suggest" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future development plans for NKTR-255 in both liquid and solid tumors and as alone or in combination with other agents (such as avelumab), the potential benefits of clinical collaborations and the timing and the availability of results from clinical studies. 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) our statements regarding the therapeutic potential of NKTR-255 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) NKTR-255 is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) NKTR-255 is in early clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes or competitive factors; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the
View original content to download multimedia:https://www.prnewswire.com/news-releases/nektar-announces-new-clinical-collaboration-with-merck-kgaa-darmstadt-germany-and-pfizer-inc-to-combine-nktr-255-a-novel-interleukin-15-agonist-with-avelumab-in-the-javelin-bladder-medley-study-301380966.html