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Confirmatory open-label, single-arm, multicenter phase 2 study of the BiTE antibody blinatumomab in patients (pts) with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL).
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Blinatumomab, an investigational bispecific T-cell engaging (BiTE) antibody that directs cytotoxic T-cells to CD19-expressing target cells, has shown antileukemia activity in an exploratory study in adult r/r B-precursor ALL. We evaluated blinatumomab efficacy and toxicity in a large confirmatory phase 2 study. Methods: Pts (≥18 yrs) with Ph-negative r/r ALL (refractory; 1st relapse <12 mo; relapse post HSCT <12 mo; ≥2ndsalvage) were eligible. Blinatumomab was given by continuous IV infusion (4 wks on/2 wks off) for up to 5 cycles (cycle 1 only: 9 μg/d days 1-7; then 28 μg/d). The primary endpoint was complete remission (CR) or CR with partial hematological recovery (CRh*) within the first 2 cycles. Results: 189 pts were enrolled and received blinatumomab for a median (range) of 2 (1–5) cycles. Median age was 39 (18–79) yrs. As of Jan 2014 (primary analysis in Feb 2014), 43% of pts achieved CR/CRh*; 80% of responses occurred within cycle 1. CRs/CRh* were seen in all subgroups (Table). Regardless of causality, the most frequent adverse events (AEs) were pyrexia (59%), headache (35%) and febrile neutropenia (29%). The most frequent gr ≥3 AEs were febrile neutropenia (26%), anemia (15%) and neutropenia (15%); 2% had gr ≥3 cytokine release syndrome. The most common gr ≥3 nervous system disorders were headache (4%), encephalopathy (3%) and ataxia (2%). 3 (2%) pts had gr 5 AEs considered treatment-related (sepsis, n=2; candida infection, n=1). Conclusions: This large phase 2 study confirmed the antileukemia activity of single-agent blinatumomab in a difficult-to-treat population with r/r ALL. Clinical trial information: NCT01466179.
|All patients
|CR/CRh*, n (%)a
Prior aHSCT (n=64)
No prior aHSCT:
No prior salvage (n=25)
1 prior salvage (n=47)
≥2 prior salvages or primary refractory (n=53)
|82 (43)
30 (47)
10 (40)
24 (51)
18 (34)
|CR, n (%)a
|64 (34)
|CRh*, n (%)a
|18 (10)
|Median relapse-free survival, mo (95% CI)
|5.9 (5.0–8.4)
|Median OS, mo (95% CI)
|6.1 (4.2–7.5)
|Minimal residual disease (MRD) response, n (%)a
|61 (74)
Abbreviation: aHSCT, allogeneic stem cell transplantation. a First two cycles (central review).
Abstracts by Max S. Topp:
Updated phase I data of AFM13: A bispecific tandem antibody (TandAb) in relapsed/refractory (R/R) Hodgkin lymphoma (HL).Meeting: 2014 ASCO Annual Meeting | Abstract No: 3025^
Immunopharmacodynamic response to blinatumomab in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).Meeting: 2013 ASCO Annual Meeting | Abstract No: 7020
Presentations by Max S. Topp:
Confirmatory open-label, single-arm, multicenter phase 2 study of the BiTE antibody blinatumomab in patients (pts) with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL).Meeting: 2014 ASCO Annual Meeting Abstract No: 7005^Session: Leukemia, Myelodysplasia, and Transplantation (Oral Abstract Session)


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1 In 4 Teenagers Engage In 'Sexting'
More than one-in-four young people said they had been involved in "sexting" of some type, according to a new Associated Press-MTV poll.
"Sexting", which includes sharing explicit videos, chat or photographs via cell phone or the Internet, is quite common among young people, despite the sometimes dire consequences.
For instance, one teenage participant said he had shared naked images of himself with girlfriends, and had also shared nude photos of someone else that a friend had sent him. He was unaware at the time that teens across the country have faced serious charges for sending such images.
"That's why I probably wouldn't do it again," the AP cited the 16-year old San Francisco Bay area teen as saying.
But, personally, "I just don't see it as that big of a problem," he added.
Nearly half of those surveyed who had been involved in sexting agreed, while the other half said they knew it was a serious problem – but did it anyway despite the risks.
"There's definitely the invincibility factor that young people feel," Kathleen Bogle, a sociology professor at La Salle University in Philadelphia, told the Associated Press.
"That's part of the reason why they have a high rate of car accidents and things like that, is they think, 'Oh, well, that will never happen to me,'" said Bogle, the author of the book "Hooking Up: Sex, Dating and Relationships on Campus."
Research has shown that the brains of teenagers are not yet mature enough to consistently make sound judgments.
However, by the mid-teens, the brain's reward centers, which are involved in emotional arousal, are well developed, making teens more susceptible to peer pressure.
But by the early 20s, the brain's frontal cortex, where reasoning joins with emotion, is completely formed, enabling people to weigh consequences of their decisions.
In addition to feeling invincible, teens have a much different perception of explicit photos that might be posted online, Bogle said.
For instance, it rarely occurs to them that such images might end up in the hands of potential employers or college admissions officers, she said.
"Sometimes they think of it as a joke; they have a laugh about it."
"In some cases, it's seen as flirtation. They're thinking of it as something far less serious and aren't thinking of it as consequences down the road or who can get hold of this information. They're also not thinking about worst-case scenarios that parents might worry about."
But sexting isn't something practiced only among teens. Indeed, young adults are even more likely to have sexted, with one-in-three reported having done so, compared with one-in-four teenagers.
Thelma, a 25-year-old from Louisiana, said men have asked her more than once to send naked pictures of herself.
"It's just when you're talking to a guy who's interested in you, and you might have a sexual relationship, so they just want to see you naked," she told the AP, adding that she never complied with the requests.
"But with my current boyfriend, I did it on my own; he didn't ask me," she said, saying she was confident he would not share the images with others.
Those who sent nude images of themselves said they primarily went to a romantic interest or to someone with whom they had a relationship.
But 14 percent said they suspect the pictures were shared with others without their consent. The poll suggests such concerns may be well founded. Seventeen percent of those who received such nude pictures said they passed them along to someone else, frequently to more than just one person.
Boys were slightly more likely than girls to say they had received naked pictures or video of a person that had been circulated without the person's consent. Among the most common reasons were that they thought other people would want to see the images, they were showing off or were simply bored.
Although girls were slightly more likely to send pictures of themselves, boys were more likely to say that sexting is "hot", while most girls calling the practice "slutty."
In total, 10 percent of the survey participants said they had sent naked pictures of themselves on their cell phone or through the Internet.
The consequences of sexting can often be grim, ranging from criminal charges to suicide.
Last year in Cincinnati, 18-year-old Jessica Logan hanged herself after weeks of being taunted at school after she sent a nude cell phone picture of herself to her boyfriend, who later forwarded it to others after the pair broke up.
And just three months ago, 13-year-old Hope Witsell of Tampa, Florida hanged herself after relentless harassment from classmates. She too had sent a nude photo of herself to a boy she liked, but another girl used his phone to send the image to students who distributed it to others throughout the school.
And other teenage suicides have been linked to online bullying. According to the AP-MTV poll, 50 percent of all young people reported having been targets of online bullying.
Such harassment can often include someone writing something negative or untrue about them on the Internet, or someone sharing private e-mails or instant messages.
More serious forms of bullying can include taking pictures or video of someone in a sexual situation and sharing it with others.
The AP-MTV poll is part of an MTV initiative known as "A Thin Line" that seeks to halt the spread of digital abuse.
The survey was conducted Sept. 11-22 by Knowledge Networks, and included online interviews with 1,247 participants aged 14-24. It has a margin of sampling error of plus or minus 2.8 percentage points.
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