Oncology Experts Highlight Practice-Changing Abstracts at ASH 2017

Gina Columbus @ginacolumbusonc
Published: Thursday, Dec 07, 2017

“There are data that suggest that if [patients] fail ICE (ifosfamide, carboplatin, and etoposide), you can salvage them with R-DHAP…which is against what everyone thought,” said Younes. “The platinum agents may not be created equal, but this is not a platinum by itself—there are other things with these platinum compounds. It is interesting because they did not record or specify the type of platinum needed in the salvage regimen. This is practice changing—even though these are small numbers you have to give the patient the benefit of the doubt, and most of us would now use an oxaliplatin regimen in the frontline setting.”

John P. Leonard, MD, professor at Weill Cornell Medicine/NewYork-Presbyterian Hospital, commented, “I’d like to study it a little bit more, but it is certainly a reasonable thing. There is no big downside to using oxaliplatin in the big picture…so it’s certainly worth considering.”

John P. Leonard, MD
John P. Leonard, MD
Efficacy and safety of acalabrutinib monotherapy in patients with relapsed/refractory MCL in the phase II ACE-LY-004 study (Abstract 155)

The phase II ACE-LY-004 study investigated monotherapy with the highly selective covalent BTK inhibitor acalabrutinib (Calquence) in patients with relapsed/refractory MCL. In October 2017, the FDA granted an accelerated approval to acalabrutinib as a treatment for adult patients with MCL following at least 1 prior therapy, which arrived several months ahead of expectations under the Prescription Drug User Fee Act.

“About 100 patients with relapsed MCL were treated with second-generation BTK inhibition, which is more selective, so we don’t expect it to be more effective because it binds to the same binding site as ibrutinib (Imbruvica),” Younes explained.

“We expect it to be safer with fewer side effects. At face value, you think this is more effective than ibrutinib because the complete response (CR) rate is higher, but one needs to be careful that they use different response criteria. If you compare them head to head, there is really not much of a difference. It certainly is an interesting agent that needs to be looked at with longer follow-up.”

Long-term follow-up ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axi-cel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL; Abstract 578)

In October 2017, the FDA approved the CD19-directed CAR T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) as a treatment for adults with relapsed or refractory NHL, making it the second CAR T-cell therapy approval this year and overall. This abstract includes the 1-year follow-up with a data cutoff of August 11, 2017 of the ZUMA-1 trial, which was the basis for the axi-cel approval in patients with refractory diffuse large B-cell lymphoma, transformed follicular lymphoma, or primary mediastinal large B-cell lymphoma.

“Everybody wants to see how many will remain in CR at 1 year because this is a good benchmark for patients with DLBCL,” said Younes, citing additional CAR T-cell studies at the meeting. “The other ones are interesting, but they still have short-term follow-up.”

Long-term follow-up of the PRIMA Study: half of patients receiving rituximab maintenance remain progression free at 10 years (Abstract 486)

The phase III PRIMA trial investigated the benefit of maintenance rituximab (Rituxan) for 2 years after patients with follicular lymphoma demonstrated responses to frontline R-CHOP induction regimens. Median 3- and 6-year follow-up results showed a significant improvement in patients who received the maintenance treatment over observation. At the 2017 ASH Annual Meeting, an additional 4 years of follow-up will be presented.

“Clearly, the data are a very nice 10-year follow-up and the median PFS is about 10 years; it’s remarkable,” commented Younes. “However, you have to put this into context because there is a parallel trial from Italy…which did not use maintenance with R-CHOP and also reported 10-year follow-up and was published in the [Journal of Clinical Oncology] with about a 10-year PFS. It is confusing for the average person. For now, I reserve the maintenance for select patients; my default is not to use maintenance for the majority of patients.”

Leonard added, “I agree. I would say I have talked about it with my patients but, in the absence of an OS benefit, the patient has a lot of flexibility. Some people want to push being able to stay in remission, while the others say ‘I’d rather take a break from coming in for therapy.’ The good news for patients is that they have a choice, which is certainly nice.”

Results from a phase I/II study of brentuximab vedotin in combination with nivolumab (Opdivo) in patients with relapsed or refractory Hodgkin lymphoma (Abstract 649)

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