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10/06/15 02:00:07 PM

Movers: Bristol-Myers Squibb Company, E. I. du Pont de Nemours and Company

Bristol-Myers Squibb Company(BMY) : Bristol-Myers Squibb Company has received the FDA approval for Opdivo in combination with Yervoy, indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Today's announcement marks the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The approval is based on data from the pivotal study, CheckMate -069, which was the first to report outcomes of the Opdivo + Yervoy Regimen in previously untreated patients with unresectable or metastatic melanoma. Results from the trial demonstrated a statistically significant (p Complete responses were seen in 17% of patients. Partial responses were seen in 43% of the Regimen group and 11% of the Yervoy monotherapy group. The Opdivo + Yervoy Regimen demonstrated a 60% reduction in the risk of progression vs. Yervoy alone (HR=0.40; 95% CI: 0.22-0.71; p Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, other adverse reactions; infusion reactions; and embryofetal toxicity. "Targeting the immune system in the treatment of cancer has been of interest to the oncology community for decades, and our first Immuno-Oncology agent, Yervoy, was approved in 2011 for metastatic melanoma. Opdivo reinforced the power of the immune system in the fight against cancer, and is quickly becoming a foundational component in how the oncology community treats this devastating disease," said Giovanni Caforio, CEO, Bristol-Myers Squibb. "Today's approval of the Opdivo + Yervoy Regimen marks another first for our research in Immuno-Oncology and represents our unwavering commitment to continually redefine cancer care, and offer patients new treatment options with the goal of improved outcomes." CheckMate -069 is a Phase II, double-blind, randomized study which enrolled 140 patients with previously untreated unresectable or metastatic melanoma, and included patients with both BRAF wild-type and BRAF mutation-positive melanoma. The primary endpoint was objective response rate (ORR) in patients with BRAF wild-type tumors. Additional efficacy outcome measures were investigator-assessed duration of response and progression-free survival (PFS) in patients with BRAF V600 wild-type melanoma. Randomization was stratified by BRAF mutation status. The Regimen includes four cycles of the Opdivo + Yervoy combination followed by Opdivo monotherapy. In the clinical study, patients in the Opdivo + Yervoy Regimen group received Opdivo 1mg/kg plus Yervoy 3mg/kg every 3 weeks for 4 doses during the combination phase, followed by Opdivo 3mg/kg every 2 weeks during the monotherapy phase. Treatment was continued until progression or unacceptable toxicity. In the Yervoy monotherapy group, patients were treated with Yervoy 3mg/kg every 3 weeks for 4 doses with matched placebo. Of the 95 patients randomized to receive the Opdivo + Yervoy Regimen, 50% were 65 years or older and 13% were 75 years or older. Fifty-nine percent of patients completed all 4 doses in the initial combination phase over a median of 9.1 weeks (range: 9.0 weeks to 26.3 weeks). Among patients (n=109) with BRAF wild-type melanoma, the Regimen demonstrated a significantly superior response rate of 60% (95% CI: 48-71; p The remaining 21% (9/43) of patients had a duration of response ranging from 3 to 7 months and have progressed after response, died, or received subsequent therapy. Along with higher ORR and more complete responses, the Opdivo + Yervoy Regimen demonstrated a 60% reduction in the risk of progression among BRAF wild-type patients vs. Yervoy alone (HR=0.40, 95% CI: 0.22-0.71; p In CheckMate -069, serious adverse reactions (62% vs. 39%), adverse reactions leading to permanent discontinuation (43% vs. 11%) or dose delays (47% vs. 22%), and Grade 3 or 4 adverse reactions (69% vs. 43%) all occurred more frequently in patients receiving the Opdivo + Yervoy Regimen compared with those receiving Yervoy alone. In the Opdivo + Yervoy Regimen group, 27% (25/94) of patients did not complete all four cycles of the Opdivo + Yervoy Regimen. The first occurrence of a Grade 3 or 4 adverse reaction was during administration of the Opdivo + Yervoy Regimen in 56 patients (59%), while 9 patients (10%) experienced first occurrence of a Grade 3 or 4 adverse reaction during administration of Opdivo alone. The most common adverse reactions leading to discontinuation of Opdivo, as compared to Yervoy alone, were colitis (16% vs. 2%), diarrhea not treated with corticosteroids (4% vs. 4%), increased ALT levels (4% vs. 0), pneumonitis (3% vs. 0), and AST increase (3% vs. 0). The most frequent serious adverse events with the Opdivo + Yervoy Regimen, as compared to Yervoy alone, were colitis (17% vs. 9%), diarrhea (9% vs. 7%), pyrexia (6% vs. 7%), and pneumonitis (5% vs. 0). The most common adverse reactions (greater than or equal to 20%) reported in patients receiving the Opdivo + Yervoy Regimen vs. Yervoy alone were rash (67% vs. 57%), pruritus (37% vs. 26%), headache (24% vs. 20%), vomiting (23% vs. 15%), and colitis (22% vs. 11%).

E. I. du Pont de Nemours and Company(DD) : Shares of E I Du Pont De Nemours And Co (NYSE: DD) spiked higher by 10 percent on Tuesday. DuPont announced on Monday its CEO Ellen Kullman will retire, cut its fiscal 2015 operating earnings per share guidance to around $2.75 from a previous $3.10. Vincent Andrews of Morgan Stanley maintained an Equal-weight rating on DuPont with a price target lowered to $50 from a previous $57. DuPont communicated several key developments with investors on Monday. DuPont stated that its CEO and Chairman Ellen Kullman will retire and replaced with Edward Breen on an interim basis. The company also lowered its fiscal 2015 operating earnings per share from $3.10 to approximately $2.75. Commenting on the revised outlook, the company noted "continued strengthening of the U.S. dollar versus currencies in emerging markets, particularly the Brazilian Real; and a further weakening of agricultural markets, primarily in Brazil." Vincent Andrews of Morgan Stanley stated in a note that on the one hand, a change in senior management can lead to, 1) corporate break-up/M&A activity in agriculture, 2) more aggressive restructuring that what was already announced, 3) potential board appointment of shareholder and activist investor Nelson Peltz. On the other hand, Andrews suggested that capital markets have already contemplated these scenarios over the prior 18 months. Andrews noted that "it will be hard for the market not to read something" into Ed Breen being named as interim CEO and Chairman as there was no commentary on the conference call. In addition, Breen successfully optimized Tyco's corporate structure through various asset separations - an issue that the board will now reconvene over. Bottom line, Andrews argued that there are "many outcomes" that are possible at this point and it is difficult to assign probabilities.


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