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Nektar and Bristol Myers Squibb Announce Update on Clinical Development Program for BEMPEG in Combination with Opdivo

PRINCETON, N.J. and SAN FRANCISCO, April 18, 2022 . Nektar Therapeutics (NASDAQ: NKTR) and Bristol Myers Squibb (NYSE: BMY) today announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer, the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo. These studies and all other ongoing studies in the program will be discontinued.

In the Phase 3 PIVOT-09 study in patients with previously untreated advanced or metastatic RCC, Nektar and Bristol Myers Squibb were informed by an independent Data Monitoring Committee (DMC) that a final analysis of objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) showed that bempegaldesleukin in combination with Opdivo did not meet the prespecified boundary for statistical significance in comparison to the tyrosine kinase inhibitor (TKI) control arm in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate/poor-risk or all-risk populations. An interim analysis of overall survival (OS) also did not meet the prespecified boundary for statistical significance in either of these populations. Given there was no clinical benefit in the doublet therapy arm compared to the TKI arm, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint.

In the separate Phase 2 PIVOT-10 study of the bempegaldesleukin/Opdivo doublet in patients with cisplatin-ineligible, locally advanced or metastatic urothelial cancer, a final ORR analysis assessed by BICR showed that bempegaldesleukin in combination with Opdivo did not reach an efficacy threshold to support continuing the program in urothelial carcinoma.

The companies will review the data for both studies and plan to share the results with the scientific community.

All other studies of bempegaldesleukin in combination with Opdivo, including a pivotal study in muscle-invasive bladder cancer (CA045-009), a Phase 1/2 study of the doublet in combination with TKI therapy in 1L RCC (CA045-011) and a Phase 1/2 study in recurrent and/or refractory pediatric tumors (CA045-020), will be discontinued, allowing patients and their physicians to consider standard of care treatment options for their specific conditions.

"As a leader in developing innovative therapies for patients with cancer, we are committed to continuing to explore novel combinations and pathways and advancing research that may help cancer patients achieve better outcomes," said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. "We are immensely grateful to the patients and investigators who participated in these studies."

The companies previously announced in March that two pivotal studies in melanoma would be discontinued based on results in the Phase 3 PIVOT IO-001 study in metastatic melanoma. Over the coming months, the companies will work jointly to discontinue the clinical program for bempegaldesleukin in combination with Opdivo.

"We thank BMS for their collaboration on the studies of bempegaldesleukin. Nektar remains dedicated to the development of therapeutics to treat cancer and auto-immune disease," said Jonathan Zalevsky, chief research and development officer of Nektar Therapeutics.

About PIVOT-09
PIVOT-09 is a global, randomized Phase 3 study evaluating bempegaldesleukin combined with Opdivo versus investigator's choice of a tyrosine kinase inhibitor (TKI) therapy (either sunitinib or cabozantinib) in patients with previously untreated advanced renal cell carcinoma in the IMDC all-risk and the IMDC intermediate- or poor-risk categories. A total of 623 patients were randomized 1:1 to receive a combination of bempegaldesleukin 0.006 mg/kg and Opdivo 360 mg every three weeks in an outpatient setting by intravenous infusion or a specified dose of TKI therapy. Patients were treated until disease recurrence, unacceptable toxicity or withdrawal of consent for up to 24 months. The study is sponsored and conducted by Nektar Therapeutics.

About PIVOT-10
PIVOT-10 is a global Phase 2 single-arm study evaluating bempegaldesleukin combined with Opdivo in patients deemed ineligible for cisplatin therapy including those whose baseline tumor cells express low levels of PD-L1. A total of 192 patients were enrolled and patients were treated until disease recurrence, unacceptable toxicity or withdrawal of consent for up to 24 months. The study is sponsored and conducted by Nektar Therapeutics.

About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 13.9%.

About Urothelial Carcinoma
Bladder cancer is the 10th most common cancer in the world, with more than 573,000 new cases diagnosed annually. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence are high. Approximately 50% of patients who undergo surgery for muscle-invasive disease will experience disease recurrence. Additionally, approximately 20% to 25% of patients with urothelial carcinoma develop metastatic disease. For patients with metastatic cancer, the prognosis is poor, with a median overall survival of approximately 12 to 14 months when treated with systemic therapy. The poor durability of responses in the first-line setting presents a major challenge in the treatment of metastatic disease, and there are limited treatment options in the second-line setting for patients with advanced urothelial carcinoma.

Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients' lives through science. The goal of the company's cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient's life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo's leading global development program is based on Bristol Myers Squibb's scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company's Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Among other risks, there can be no guarantee that the collaboration with Nektar will progress as contemplated in this release or that NKTR-214, alone or in combination with Opdivo or Opdivo plus Yervoy will receive regulatory approval for the treatment of cancer. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Nektar Therapeutics Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "will," "may," "plan," "advance" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the future plans regarding bempegaldesleukin, approaches for winding down clinical trials and future research efforts. 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 bempegaldesleukin are subject to change; (ii) winding down clinical trials is complicated and time-consuming, and may incur difficulties and expenses due to a number of factors outside of our control; and (iii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2022. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Posted: April 2022

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