ORLANDO, Fla. – Not long past the opening of the American Society of Hematology’s (ASH) massive annual conference, Janssen Biotech Inc. released upbeat follow-up survivability data on Imbruvica (ibrutinib) from two studies and an integrated analysis evaluating Imbruvica in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The 48-month follow-up analysis of the phase III E1912 study reported a statistically significant difference in progression-free survival (PFS) and overall survival (OS) for Imbruvica plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR). Integrated analysis from the phase III Resonate (PCYC-1112) and Resonate-2 (PCYC-1115/1116) studies of Imbruvica in CLL reported that, at up to six years of follow-up, PFS, OS and response rates improved in earlier lines of therapy. Imbruvica was tolerated across all lines of therapy, with adverse events prompting 19% of patients to discontinue.

The phase II Captivate study suggests that patients receiving Imbruvica plus venetoclax as a time-limited treatment reached high rates of undetectable minimal residual disease in peripheral blood (75% of patients) and bone marrow (72% of patients). Captivate encompassed 164 patients, all under age 70 with previously untreated CLL/SLL, who received Imbruvica monotherapy as lead-in treatment for three cycles, followed by 12 cycles of Imbruvica plus venetoclax combination therapy.

Imbruvica is an oral, once-daily BTK inhibitor. BTK tells B cells to produce antibodies, which are needed by specific cancer cells to multiply and spread. It is developed and commercialized by Janssen Biotech Inc. and Abbvie Inc.

Overcoming obstacles to CAR T

With nearly 5,000 abstracts at this year’s ASH, a key theme includes overcoming obstacles to CAR T therapy. Early Saturday, Deepu Madduri, of the Icahn School of Medicine at Mount Sinai, presented the first data taken from Janssen’s phase Ib/II Cartitude-1 study of JNJ-4528, a dual B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, showing response from patients with relapsed/refractory multiple myeloma. The patient response rate was 100%, with 69% having a complete response or better. The FDA granted breakthrough therapy designation to JNJ-4528 Dec. 6, 2019.

Madduri was among three other researchers this morning who spoke about CAR T therapy.

Stephen Schuster, of the Abramson Cancer Center at the University of Pennsylvania, mentioned how antibody-based immunotherapy mosunetuzumab is used as a bridge to CAR T therapy.

“The future for this off-the-shelf application is the direction that we’ll be pursuing in the future,” Schuster said.

As for the next chapter, he said, “the easy path is looking at the survival of those failing CAR T.”

Bob Valamehr, chief development officer at Fate Therapeutics Inc., noted that CAR T changed the way cancer is treated. There are problems – he noted “complex logistics, the cost is high, and limited availability” – but the process is highly scalable. Each dose, he said, is about $2,500.

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