Bristol-Myers Squibb (BMY) Announces New Data from Opdivo Phase 2 in cHL; ORR was 73% Across Subgroups

October 25, 2016 8:01 AM EDT

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Bristol-Myers Squibb Company (NYSE: BMY) announced new results from CheckMate -205, a multi-cohort, single-arm, Phase 2 trial evaluating Opdivo (nivolumab) in patients with classical Hodgkin lymphoma (cHL). These results from cohort C (n=100) of the trial included patients with cHL who had received brentuximab vedotin before and/or after autologous hematopoietic stem cell transplantation (auto-HSCT). After a median follow-up of 8.8 months, the primary endpoint of objective response rate (ORR) per an independent radiologic review committee (IRRC) was 73% (n=73; 95% CI: 63.2-81.4) overall, which was consistent across patient subgroups regardless of the timing of prior brentuximab vedotin relative to auto-HSCT. The ORR was 70% (n=23; 95% CI: 51.3-84.4) in patients who received brentuximab vedotin only before auto-HSCT; 72% (n=41; 95% CI: 58.5-83.0) in patients who received brentuximab vedotin only after auto-HSCT; and 88% (n=7; 95% CI: 47.3-99.7) in patients who received brentuximab vedotin before and after auto-HSCT. The safety profile of Opdivo was consistent with previously reported data in this tumor type, and no new clinically meaningful safety signals were identified.

These data will be presented at the 10th International Symposium on Hodgkin Lymphoma (ISHL) in Cologne, Germany on Tuesday, October 25 at 3:00 p.m. CEST (Abstract #0149). This abstract was awarded the Karl Musshoff Prize for the Best Clinical Research Abstract, which is granted every three years in conjunction with ISHL for outstanding results in the field of Hodgkin lymphoma.

“These data from cohort C build on existing evidence supporting the benefit of Opdivo in classical Hodgkin lymphoma patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin,” said Andreas Engert, M.D., study investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany. “Results from cohort C indicated a benefit with Opdivo regardless of the order of prior treatment with autologous hematopoietic stem cell transplantation and brentuximab vedotin, providing important insights as we continue researching the potential role Opdivo could provide for heavily pre-treated classical Hodgkin lymphoma patients.”

In May 2016, the U.S. Food and Drug Administration approved Opdivo for the treatment of patients with cHL who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin based on a combined analysis of data from cohort B of CheckMate -205 and the Phase 1 CheckMate -039 trial. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In October 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of Opdivo for the treatment of adult patients with relapsed or refractory cHL after auto-HSCT and treatment with brentuximab vedotin based on data from cohort B of CheckMate -205 and CheckMate -039. The CHMP recommendation is now being reviewed by the European Commission, which has the authority to approve medicines for the European Union. Opdivo also is currently under regulatory review for cHL in Japan.

Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb, commented, “We continue to expand our Immuno-Oncology science in hematology, and these latest results from CheckMate -205 will help inform our research into classical Hodgkin lymphoma and aid us in determining whether Opdivo may provide benefit to a broader population of patients living with this difficult-to-treat disease.”

About CheckMate -205 Cohort C

Key efficacy results from cohort C of CheckMate -205 are summarized below.

Cohort COverall(n=100)

BV Only BeforeAuto-HSCTSubgroup(n=33)

BV Only AfterAuto-HSCTSubgroup(n=57)

BV Before andAfter Auto-HSCTSubgroup (n=8)

ORR per IRRC, n (%)

[95% CI]

73 (73)

[63.2, 81.4]

23 (70)

[51.3, 84.4]

41 (72)

[58.5, 83.0]

7 (88)

[47.3, 99.7]

Complete response, n (%)

[95% CI]

17 (17.0)

[10.2, 25.8]

6 (18.2)

[7.0, 35.5]

7 (12.3)

[5.1, 23.7]

3 (38)

[8.5, 75.5]

Partial response, n (%)

[95% CI]

56 (56.0)

[45.7, 65.9]

17 (51.5)

[33.5, 69.2]

34 (59.6)

[45.8, 72.4]

4 (50.0)

[15.7, 84.3]

6-month PFS rate per IRRC, %

[95% CI]

76.6

[66.3, 84.2]

83.7

[65.1, 92.9]

71.2

[56.7, 81.6]

83.3

[27.3, 97.5]

Median PFS, months

[95% CI]

11.2

[8.5, NA]

11.2

[8.5, NA]

8.9

[8.3, NA]

NA

[5.6, NA]

Median DOR, months

[95% CI]

7.0

[6.7, NA]

7.0

[6.7, NA]

NA

[5.4, NA]

NA

[3.3, NA]

6-month OS, %

[95% CI]

93.9

[86.9, 97.2]

97

[80, 100]

91

[80, 96]

100

[100, 100]

In CheckMate -205 cohort C, the safety profile of Opdivo was consistent with previously reported data in this tumor type, and no new clinically meaningful safety signals were identified. Treatment-related adverse events (AE) occurred in 68% of patients between the first dose and 30 days after the last dose of Opdivo. The most common treatment-related AEs were diarrhea, infusion-related reaction and fatigue (11% each). Grade 3/4 AEs occurred in 19% of patients. Serious treatment-related AEs were reported in 17% of patients, and treatment-related AEs leading to discontinuation occurred in 6% of patients. At present, no treatment-related deaths have been reported.

About CheckMate -205

CheckMate -205 is a Phase 2, open-label, international, multicenter, non-comparative, multi-cohort study that evaluated the safety and efficacy of Opdivo in adult patients with classical Hodgkin lymphoma (cHL). Cohort A included cHL patients who had received autologous hematopoietic stem cell transplantation (auto-HSCT) and who were brentuximab vedotin-naïve (n=63); cohort B included cHL patients who had received auto-HSCT followed by brentuximab vedotin (n=80); and cohort C included cHL patients who had received brentuximab vedotin before and/or after auto-HSCT (n=100). CheckMate -205 also includes cohort D, which is currently enrolling and evaluating Opdivo in combination with chemotherapy in newly diagnosed, advanced-stage cHL patients who are treatment-naïve (n=50).

Patients enrolled in this trial were treated with Opdivo 3 mg/kg intravenously every two weeks until disease progression or unacceptable toxicity; in cohort C, patients also were treated until investigator-assessed complete response (CR) lasting one year.

The primary endpoint of the study was objective response rate by independent radiologic review committee (IRRC) assessment. Secondary and other exploratory endpoints included duration of response (DOR) by IRRC assessment for CR rate and partial response rate, progression-free survival (PFS) by IRRC assessment, overall survival (OS) and safety.

About Classical Hodgkin Lymphoma

Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. Worldwide, there are about 66,000 new HL cases and 25,500 deaths from HL estimated each year. The disease is most often diagnosed in early adulthood (ages 20-40) and late adulthood (older than 55 years of age). Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases. There remains a significant unmet need for patients who relapse or who become refractory to approved treatments that are currently available.



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