We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol-Myers Presents Data on Immuno-Oncology Drug Opdivo
Read MoreHide Full Article
Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Commission (EC) has approved immuno-oncology drug Opdivo for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy.
Opdivo is approved for varied indications around the world like metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) among others. The FDA approved Opdivo for the treatment of patients with previously treated locally advanced or mUC in Feb 2017.
Concurrently, Bristol-Myers entered into a collaboration agreement with Seattle Genetics, Inc. to evaluate the combination of Opdivo and Seattle Genetics’ antibody drug conjugate (ADC) Adcetris in a phase III trial as a potential treatment option for patients with relapsed/refractory or transplant-ineligible advanced classical Hodgkin lymphoma (HL). The trial will being in mid-2017.
Also, Bristol-Myers presented a series of data on Opdivo from various ongoing trials at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017.
The company announced data from a cohort of the phase I/II study, CheckMate-358 evaluating Opdivo for the treatment of patients with advanced cervical, vaginal and vulvar cancers, associated with infection by the human papillomavirus (HPV). The data showed an overall response rate of 26.3% in patients with cervical cancer regardless of PD-L1, HPV status and number of prior systemic therapies.
Bristol-Myers also announced encouraging proof-of-concept data showing preliminary efficacy for BMS-986016, an investigational anti-lymphocyte-activation gene 3 (LAG-3) therapy in combination with Opdivo in patients with advanced melanoma previously treated with anti-PD-1/PD-L1 therapy. The data demonstrated encouraging activity of BMS-986016 and Opdivo combination in heavily pretreated advanced melanoma patients who were relapsed or refractory on anti-PD-1/PD-L1 therapy. The objective response rate (ORR) was 12.5% in evaluable patients in the ongoing expansion study of heavily pretreated patients who were refractory to or relapsed on anti-PD1/PDL1 therapy.
Bristol-Myers also announced interim data from a phase II study, CheckMate-142, evaluating Opdivo monotherapy or in combination with Yervoy for the treatment of patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC). The primary endpoint of investigator-assessed ORR was 54.8%. The median duration of response was not yet reached.
The nine-month overall survival (OS) rate was 87.6% and median OS had not been reached at the time of analysis. We remind investors that Opdivo in combination with Yervoy is already approved for the treatment of patients with unresectable or metastatic melanoma in the U.S.
Efficacy and safety data from another phase II study, CheckMate-204, which is evaluating the combination of Opdivo plus Yervoy as a potential treatment for patients with melanoma metastatic to the brain showed anti-tumor activity. The data showed over half of patients (55%) experienced an intracranial objective response with 21% achieving a complete intracranial response.
The company also announced results of an interim descriptive analysis from an ongoing National Cancer Institute (NCI) phase III randomized study evaluating Yervoy (ipilimumab) 3 mg/kg and Yervoy10 mg/kg in patients with stage III or resectable stage IV melanoma who are at high risk of recurrence following complete surgical resection. The data showed that relapse-free survival after three years was 56% for Yervoy 3 mg/kg and 54% for Yervoy 10 mg/kg.
In a separate news, Bristol-Myers signed an agreement with Qiagen (QGEN - Free Report) to explore the use of next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with its novel immuno-oncology (I-O) therapies in cancer treatment. Both the companies intend to develop GEPs for several Bristol-Myers’ I-O molecules under the initial agreement. Per the terms of the deal, both the companies will also develop diagnostic products using the jointly developed GEPs and to expand the use of NGS technology with other Bristol-Myers’ I-O therapies.
We note that Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classic Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016).
In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
However, the company suffered a setback in Jan 2017 when it decided not to pursue accelerated regulatory pathway for the regimen of Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of available data.Opdivo is facing competitive challenges in the U.S. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic nonsquamous NSCLC, the company is expected to suffer further loss of market share.
While Bristol-Myers’ share price decreased 29.4% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 2.4%.
Zacks Rank
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Bigstock
Bristol-Myers Presents Data on Immuno-Oncology Drug Opdivo
Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Commission (EC) has approved immuno-oncology drug Opdivo for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy.
Opdivo is approved for varied indications around the world like metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) among others. The FDA approved Opdivo for the treatment of patients with previously treated locally advanced or mUC in Feb 2017.
Concurrently, Bristol-Myers entered into a collaboration agreement with Seattle Genetics, Inc. to evaluate the combination of Opdivo and Seattle Genetics’ antibody drug conjugate (ADC) Adcetris in a phase III trial as a potential treatment option for patients with relapsed/refractory or transplant-ineligible advanced classical Hodgkin lymphoma (HL). The trial will being in mid-2017.
Also, Bristol-Myers presented a series of data on Opdivo from various ongoing trials at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017.
The company announced data from a cohort of the phase I/II study, CheckMate-358 evaluating Opdivo for the treatment of patients with advanced cervical, vaginal and vulvar cancers, associated with infection by the human papillomavirus (HPV). The data showed an overall response rate of 26.3% in patients with cervical cancer regardless of PD-L1, HPV status and number of prior systemic therapies.
Bristol-Myers also announced encouraging proof-of-concept data showing preliminary efficacy for BMS-986016, an investigational anti-lymphocyte-activation gene 3 (LAG-3) therapy in combination with Opdivo in patients with advanced melanoma previously treated with anti-PD-1/PD-L1 therapy. The data demonstrated encouraging activity of BMS-986016 and Opdivo combination in heavily pretreated advanced melanoma patients who were relapsed or refractory on anti-PD-1/PD-L1 therapy. The objective response rate (ORR) was 12.5% in evaluable patients in the ongoing expansion study of heavily pretreated patients who were refractory to or relapsed on anti-PD1/PDL1 therapy.
Bristol-Myers also announced interim data from a phase II study, CheckMate-142, evaluating Opdivo monotherapy or in combination with Yervoy for the treatment of patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC). The primary endpoint of investigator-assessed ORR was 54.8%. The median duration of response was not yet reached.
The nine-month overall survival (OS) rate was 87.6% and median OS had not been reached at the time of analysis. We remind investors that Opdivo in combination with Yervoy is already approved for the treatment of patients with unresectable or metastatic melanoma in the U.S.
Efficacy and safety data from another phase II study, CheckMate-204, which is evaluating the combination of Opdivo plus Yervoy as a potential treatment for patients with melanoma metastatic to the brain showed anti-tumor activity. The data showed over half of patients (55%) experienced an intracranial objective response with 21% achieving a complete intracranial response.
The company also announced results of an interim descriptive analysis from an ongoing National Cancer Institute (NCI) phase III randomized study evaluating Yervoy (ipilimumab) 3 mg/kg and Yervoy10 mg/kg in patients with stage III or resectable stage IV melanoma who are at high risk of recurrence following complete surgical resection. The data showed that relapse-free survival after three years was 56% for Yervoy 3 mg/kg and 54% for Yervoy 10 mg/kg.
In a separate news, Bristol-Myers signed an agreement with Qiagen (QGEN - Free Report) to explore the use of next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with its novel immuno-oncology (I-O) therapies in cancer treatment. Both the companies intend to develop GEPs for several Bristol-Myers’ I-O molecules under the initial agreement. Per the terms of the deal, both the companies will also develop diagnostic products using the jointly developed GEPs and to expand the use of NGS technology with other Bristol-Myers’ I-O therapies.
We note that Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classic Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016).
In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
However, the company suffered a setback in Jan 2017 when it decided not to pursue accelerated regulatory pathway for the regimen of Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of available data.Opdivo is facing competitive challenges in the U.S. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic nonsquamous NSCLC, the company is expected to suffer further loss of market share.
While Bristol-Myers’ share price decreased 29.4% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 2.4%.
Zacks Rank
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>