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J&J's Blood Cancer Drugs Succeed in Label Expansion Studies

Johnson & JohnsonJNJ presented positive data from late-stage label expansion studies evaluating its blood cancer drugs, Imbruvica and Darzalex, in previously untreated patients at the annual meeting of the American Society of Hematology (ASH) held in San Diego, CA.

New findings from a phase III study showed that its key cancer drug, Imbruvica, as a combination therapy, significantly improved survival compared to standard chemo immunotherapy regimen in previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. J&J markets Imbruvica in partnership with AbbVie ABBV .

With nearly three years of follow-up, interim data from the E1912 head-to-head study showed that Imbruvica in combination with Roche's RHHBY Rituxan significantly prolonged progression-free survival (PFS), the primary endpoint of the study, as a first-line treatment for CLL/SLL patients aged 70 or younger compared to fludarabine, cyclophosphamide and rituximab (FCR). The Imbruvica combination therapy resulted in a 65% reduction in the risk of progression or death. Moreover, the combination significantly improved overall survival (OS) compared to FCR. Note that FCR is the most commonly used treatment regimen for younger patients with CLL.

At ASH, J&J also presented data from a phase III study (MAIA) evaluating Darzalex in combination with standard of care treatment regimen - Celgene's CELG Revlimid (lenalidomide) and dexamethasone (Rd) - in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). At a median follow-up of 28 months, the data showed that the addition of Darzalex to Rd significantly reduced the risk of disease progression or death by 44% in such patients compared to treatment with Rd alone. While PFS for patients who received Rd alone was 31.9 months, the median PFS for Darzalex plus Rd arm was not reached. The complete response rates and very good partial response (VGPR) rates were also higher in the patients receiving Darzalex plus Rd versus those receiving Rd alone.

Based on the data from the MAIA study, J&J plans to file supplemental biologics license application (sBLA) for FDA approval of Darzalex in this patient population.

We remind investors that in May, Darzalex was approved in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT.

So far this year, J&J's stock has risen 4.7% compared with an increase of 10.4% recorded by the industry .

Both Darzalex and Imbruvica are key drugs in J&J's oncology portfolio and contribute significantly to the drug giant's top line. Darzalex recorded sales of $1.4 billion in the first nine months of 2018, rising 65.4% on a year-over-year basis. Imbruvica sales in the same period were $1.9 billion, up almost 40%.

Imbruvica is currently approved for nine indications across six different cancer types and the drug is also being evaluated in a number of combination therapies. Darzalex, presently marketed for multiple myeloma in patients who have received at least three prior lines of therapy, is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in front-line and relapsed settings.

J&J currently has a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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