Full Press Release Details
Bristol Myers Squibb and Nektar Announce Update
on Phase 3 PIVOT IO-001 Trial Evaluating Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) in Previously Untreated
Unresectable or Metastatic Melanoma
(PRINCETON, N.J., & SAN FRANCISCO, March 14, 2022) -- Bristol Myers Squibb (NYSE: BMY) and Nektar Therapeutics (NASDAQ: NKTR) today announced an update following the first
analysis of the Phase 3 PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo (nivolumab)
compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma. Following
a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers Squibb and Nektar were
informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed
by Blinded Independent Central Review (BICR). The DMC notified the companies that the third primary endpoint of overall survival (OS)
did not meet statistical significance at the first interim analysis.
Given there was no additional clinical benefit
in the doublet therapy arm compared to the monotherapy arm for the primary endpoints of PFS and ORR, and based on the data reviewed by
the DMC, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint. Additionally, based
on the results from PIVOT IO-001, the companies have also made the decision to discontinue enrollment and unblind the ongoing PIVOT-12
study in adjuvant melanoma, which is evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo compared to
Opdivo monotherapy in patients at high risk for recurrence after complete resection of melanoma. Patients in both studies will
be counseled on their treatment options, and permitted to continue treatment if agreed to with their physician.
The companies will review the data and plan to
share the results with the scientific community.
"As a leader in developing innovative therapies
for patients with cancer, we have continued to explore novel strategies that may expand treatment benefits to more patients with advanced
disease," said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. "We are disappointed
with the results of this trial, which we had hoped would lead to a new therapeutic option to treat metastatic melanoma. We express our
gratitude to the patients, caregivers and investigators who chose to participate in these trials."
The other four studies ongoing for bempegaldesleukin
plus Opdivo in renal cell carcinoma and bladder cancer are continuing.
"While we are surprised and deeply disappointed
in these results for the melanoma study, we will continue to await initial results from our first two ongoing studies in renal cell carcinoma
and urothelial cancer, which are currently expected in the first half of 2022," said Jonathan Zalevsky, chief research and development
officer of Nektar Therapeutics. "We look forward to collaborating with BMS to evaluate the data from these other studies to guide
the future development of bempegaldesleukin. Nektar remains dedicated to the development of therapeutics to treat cancer and auto-immune
PIVOT IO-001 is a randomized Phase 3 study evaluating
the combination of bempegaldesleukin in combination with Opdivo versus Opdivo alone in patients with previously untreated
unresectable or metastatic melanoma. The study is sponsored and conducted by Bristol-Myers Squibb. A total of 783 patients were randomized
1:1 to receive a combination of bempegaldesleukin 0.006 mg/kg and Opdivo 360 mg or Opdivo 360 mg by intravenous infusion
every three weeks in an outpatient setting. Patients were treated until disease recurrence, unacceptable toxicity or withdrawal of consent
for up to 24 months.
PIVOT-12 is a randomized Phase 3 open-label study
evaluating the adjuvant immunotherapy of bempegaldesleukin combined with Opdivo versus Opdivo alone after complete resection
of melanoma in patients at high risk for recurrence. The study is sponsored and conducted by Nektar Therapeutics.
About Nektar Therapeutics
Nektar Therapeutics is
a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology
as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California,
with additional operations in Huntsville, Alabama and Hyderabad, India.
Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
Bristol Myers Squibb: Creating a Better Future for People with
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
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.
OPDIVO (nivolumab), as a single agent, is indicated
for the treatment of adult patients with unresectable or metastatic melanoma.
OPDIVO (nivolumab), in combination with YERVOY
(ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic melanoma.
OPDIVO (nivolumab) is indicated for the adjuvant treatment
of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
OPDIVO (nivolumab), in combination with platinum-doublet
chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors 4 cm or node positive) non-small cell
lung cancer (NSCLC).
OPDIVO (nivolumab), in combination with YERVOY
(ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors
express PD-L1 ( 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO (nivolumab), in combination with YERVOY
(ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic
or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO (nivolumab) is indicated for the treatment of
adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with
EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving
OPDIVO (nivolumab), in combination with YERVOY
(ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO (nivolumab), in combination with YERVOY
(ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma
OPDIVO (nivolumab), in combination with cabozantinib,
is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO (nivolumab) is indicated for the treatment of
adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO (nivolumab) is indicated for the treatment of
adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation
(HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved
under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification