Johnson & Johnson JNJ announced initial data from a phase Ib/II CARTITUDE-1 study evaluating its CAR-T therapy candidate, JNJ-68284528. The B cell maturation antigen directed CAR-T therapy is being developed by Janssen, a subsidiary of J&J, as a potential treatment for relapsed or refractory multiple myeloma (r/rMM).
The study is evaluating the CAR-T therapy candidate in multiple myeloma patients who have received at least three prior lines of therapies and their disease has progressed on or within 12 months of their last line of therapy. Data from the study showed that JNJ-68284528 achieved a response in 100% of patients who have received a median of five prior treatment regimens at a median six-month follow-up. The complete response rate was 69% and 86% of patients achieved a very good partial response.
A partial response was achieved in 14% of the patients. Moreover, all the patients in the study achieved early minimal residual disease negative disease status. Most of the patients (27 of 29) were progression-free at six-month follow up. Based on the data from the study, 0.75x10^6 CAR+ viable T cells/kg was chosen as the recommended dose for phase II study on JNJ-68284528. The data will be presented at the American Society of Hematology (“ASH”) annual meeting, schedule on Dec 9.
J&J also announced that the FDA granted Breakthrough Therapy designation to JNJ-68284528 for treating r/rMM based on the positive initial data from the CARTITUDE-1 study.
J&J’s shares have gained 8.8% so far this year compared with the industry’s increase of 7.2%.
At ASH, J&J also presented long-term data from separate clinical studies evaluating its key cancer drug, Imbruvica, in previously untreated patients with chronic lymphocytic leukemia (“CLL”).
Follow-up data of up to six years from two phase III studies — RESONATE and RESONATE 2 — showed that Imbruvica monotherapy improved progression free survival (“PFS”), overall survival (“OS”) and response rates in previously untreated patients with CLL. Please note that J&J develops and commercializes Imbruvica in partnership with AbbVie ABBV. The drug is approved in 10 different settings in six cancer indications, including first-line CLL.
Meanwhile, data from a 48-month follow-up analysis of another phase III study, E1912, showed that Imbruvica in combination with Roche RHHBY/Biogen’s BIIB Rituxan (rituximab) achieved a statistically significant difference in PFS and OS in first-line treatment of CLL compared to a standard chemoimmunotherapy regimen.
Data from a phase II CAPTIVATE study evaluating Imbruvica in combination with Roche/AbbVie’s Venclexta (venetoclax) achieved high rates of undetectable minimal residual disease (“MRD”) in previously untreated patients with CLL for time-limited, MRD-guided combination regimen.
Last week, J&J announced a definitive agreement with privately-held XBiotech Inc. to acquire all rights to the latter’s pipeline candidate, bermekimab, for $750 million. XBiotech is developing bermekimab in mid-stage study as a potential treatment for skin disorders namely atopic dermatitis and hidradenitis suppurativa.
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J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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