Bullish options flow was detected in Bristol-Myers stock on December 11, 2019.

Bullish options flow detected in BMY stock on December 11, 2019.

The bullish options flow may be the result of the recent release of overall survival and safety data from CC-486 study QUAZAR AML-001. Treatment with CC-486 resulted in a significant improvement in overall survival compared with placebo for front-line AML patients and CC-486 had a manageable safety profile.

On December 10, 2019, Bristol-Myers Squibb Company (NYSE: BMY) announced clinical results from the QUAZAR AML-001 study, evaluating investigational agent CC-486 as maintenance therapy in a broad population of patients with front-line, newly diagnosed acute myeloid leukemia (AML) who have achieved remission with intensive induction chemotherapy. Data were presented during a late-breaker oral presentation at the 2019 ASH Annual Meeting in Orlando, Fla. In the QUAZAR AML-001 study, treatment with CC-486 in the maintenance setting provided patients a statistically significant and clinically meaningful improvement in overall survival (OS) and relapse-free survival (RFS), as compared to those patients treated with placebo.

Patients in the phase 3, international, randomized, double-blind, placebo-controlled study QUAZAR AML-001 were at least 55 years old, had de novo or secondary AML with intermediate or poor-risk cytogenetics and had achieved their first complete remission (CR) or complete remission with incomplete count recovery (CRi) after intensive induction chemotherapy. Patients had received intensive induction chemotherapy, with or without consolidation chemotherapy per investigator’s choice and were deemed not candidates for hematopoietic stem-cell transplant prior to study entry.

“Despite a number of recent advances in the treatment of AML, the prognosis remains poor, as most patients will relapse and ultimately die of their disease,” said Dr. Andrew Wei, MBBS, Ph.D., from Alfred Hospital and Monash University, Melbourne, Australia. “The role of maintenance therapy in AML has historically been a contentious issue. Based on the results of the QUAZAR study, we are excited about the clinical development of CC-486 and the potential to establish maintenance therapy as a new treatment paradigm for patients with AML in first remission.”

Following intensive induction chemotherapy, 81% of patients had achieved a CR and 19% of patients had achieved a CRi. Eighty percent of patients had received at least one cycle of consolidation therapy prior to enrollment in the study. Four hundred seventy-two patients were then randomized 1:1 to receive initially either investigational CC-486 300mg (n=238) or placebo (n=234) once daily for 14 days of each 28-day cycle. Patients remained on treatment until unacceptable toxicity or disease progression.

At a median follow-up of 41.2 months, the primary endpoint of OS was significantly improved for patients receiving CC-486 compared to placebo. Median OS from time of randomization was 24.7 months in the CC-486 arm compared to 14.8 months for placebo (p=0.0009; HR 0.69 [95% CI: 0.55, 0.86]). Median RFS, the key secondary endpoint, was 10.2 months for those receiving CC-486 compared to 4.8 months for those receiving placebo (p=0.0001; HR 0.65 [95% CI: 0.52, 0.81]). Improvements in OS and RFS for those treated with CC-486 compared to placebo were demonstrated, regardless of cytogenetic risk category, prior consolidation or CR/CRi status at enrollment. Health-related quality of life (HRQoL) was preserved from baseline for patients receiving CC-486 compared to placebo during treatment.

The median duration of treatment was 12 cycles (1-80) for CC-486 and 6 cycles with placebo (1-73). The most commonly occurring adverse events (AEs) of all grades with CC-486 and placebo, respectively, were nausea (65% vs. 24%), vomiting (60% vs. 10%) and diarrhea (50% vs. 22%). The most common grade 3-4 AEs for CC-486 and placebo, respectively, were neutropenia (41% vs. 24%), thrombocytopenia (23% vs. 22%) and anemia (14% vs. 13%). Serious AEs were reported in 34% of CC-486 patients and 25% of placebo patients, and were mainly infections, which occurred in 17% and 8% of CC-486 and placebo patients, respectively. There were 13% of CC-486 patients and 4% of placebo patients who discontinued treatment due to AEs.

“We are extremely encouraged by the results of the QUAZAR AML-001 study as a part of our continuing commitment to both epigenetic research and myeloid diseases,” said Samit Hirawat, M.D., Chief Medical Officer of Bristol-Myers Squibb. “We now look forward to taking the next steps to bring CC-486 to eligible AML patients in need.”

Based on the results of QUAZAR AML-001, Bristol-Myers Squibb is planning regulatory submissions in the first half of 2020.

On December 8, 2019, Bristol-Myers Squibb announced data from multiple studies evaluating lisocabtagene maraleucel, or liso-cel, an investigational CD19-directed CAR T-cell therapy with a defined composition of purified CD8+ and CD4+ CAR T cells, were presented during the 2019 ASH Annual Meeting. These studies included an evaluation of liso-cel in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, or TRANSCEND CLL 004; a study in second-line patients with relapsed or refractory large B-cell non-Hodgkin’s lymphoma patients who were ineligible for high-dose chemotherapy and hematopoietic stem cell transplant, or PILOT; and a separate analysis of patients with relapsed/refractory large B-cell non-Hodgkin lymphoma who received liso-cel in the outpatient setting across three studies. “As we continue to evaluate liso-cel in important new disease settings and areas of unmet medical need, we are encouraged to see the early results from these studies. The results in relapsed or refractory CLL and SLL demonstrated a high rate of durable complete responses achieved in heavily pre-treated patients, including patients who have failed ibrutinib and venetoclax. We are encouraged by the potential of liso-cel to treat second-line relapsed or refractory large B-cell NHL patients who are not able to undergo a stem cell transplant. Finally, the analysis evaluating liso-cel administered in the outpatient setting demonstrates that not all patients require hospitalization and that the safety and efficacy profile across a variety of types of clinical sites is consistent,” said Stanley Frankel, M.D., Senior Vice President, Cellular Therapy Development for Bristol-Myers Squibb.

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