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December 09, 2019___

Today's Rundown

Featured Story

Bristol-Myers' CAR-T poised for FDA filing after banishing lymphoma in 53% of patients

In a newly unveiled study, Bristol-Myers Squibb’s CAR-T therapy banished tumors in more than half of relapsed blood cancer patients and shrank tumors in nearly three-quarters of them. The treatment, picked up in the company’s $74 billion Celgene buyout, could help patients with large B-cell lymphomas whose disease has worsened despite trying other treatments. 

Top Stories

AstraZeneca's Calquence posts sky-high survival numbers in previously untreated CLL

ORLANDO—Over the last couple of weeks, regulators in the U.S., Canada and Australia have all green-lighted AstraZeneca’s Calquence in newly diagnosed chronic lymphocytic leukemia patients. And Saturday, the company unveiled more of the data that convinced them to dole out those approvals.

Eli Lilly plots 'ambitious' cancer program after sharing early BTK data

Eli Lilly shared early clinical data on the BTK inhibitor it acquired with Loxo Oncology—and the numbers are strong enough to prompt some action. Most of the heavily pretreated trial patients responded to the drug, emboldening Lilly to outline “an ambitious comprehensive development program.”

AbbVie, Roche pad their case for fixed-duration Venclexta use in CLL

ORLANDO—AbbVie and Roche have been fielding their fair share of questions about how well their fixed-duration regimen of Venclexta and Rituxan can keep chronic lymphocytic leukemia from returning after therapy ends. The companies now think they have some compelling answers.

J&J's anti-BCMA CAR-T clears multiple myeloma in 69% of patients in phase 1

Janssen’s BCMA-targeting CAR-T therapy eliminated tumors in 69% of patients with advanced multiple myeloma in a small phase 1 study. The treatment, which also shrank tumors in all 29 of the patients, kept cancer at bay in 93% of patients six months after dosing.

Gilead Sciences touts 'astounding' Yescarta survival results at 3 years

ORLANDO—How long can a single infusion of CAR-T drug Yescarta continue helping patients with refractory large B-cell lymphoma? Pretty long, Gilead Sciences showed Saturday. Nearly half of patients treated with Yescarta more than three years ago—47%—were still alive at a median follow-up of 39.1 months.

Roche bispecific delivers for hard-to-treat lymphoma patients failed by CAR-Ts

Roche has rolled out new data showing mosunetuzumab can trigger complete responses in a tough group—lymphoma patients failed by CAR-Ts and other drugs. The phase 1/2b linked the bispecific antibody to long-lasting responses in a significant minority of hard-to-treat non-Hodgkin lymphoma patients.

BeiGene, eyeing Imbruvica's CLL share, touts more early Brukinsa data

ORLANDO—BeiGene only recently won its first approval for Brukinsa with a nod in mantle cell lymphoma. But it’s already pushing to join the CLL field, and Sunday it rolled out new response-rate data that could help it toward that goal.

Takeda details Ninlaro's miss in AL amyloidosis

Back in June, Takeda scrapped a Ninlaro trial in the rare disease light-chain (AL) amyloidosis. Saturday, it shared the data behind the decision—results execs say they’re excited to get into the public domain.

Novartis trumpets hospitalization data for newly minted sickle cell drug Adakveo

With a brand-new approval for targeted sickle cell disease therapy Adakveo under its belt, Novartis showed off an analysis Sunday demonstrating the drug could cut down on patient hospitalizations by 40%.

Resources

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[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

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IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology.

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Events