FiercePharmaAsia—AZ, Daiichi's HER2 data win; J&J, Legend's CAR-T; Samsung BioLogics fraud probe

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AstraZeneca and Daiichi Sankyo, Johnson & Johnson and Legend Biotech, and Samsung BioLogics made our news this week. (Google)

The Daiichi Sankyo antibody-drug conjugate that inspired AstraZeneca to a nearly $7 billion bet has turned up what analysts called "impressive efficacy" data in HER2-driven breast cancer. After showing promising results in Chinese patients, which led to an exclusive licensing deal with Johnson & Johnson, Legend Biotech's CAR-T therapy JNJ68284528 (LCAR-B38M) again cleared multiple myeloma in 69% of patients in another phase 1b trial. A Seoul court handed three Samsung Electronics execs jail terms of up to two years for destroying evidence linked to an accounting fraud probe at CDMO unit Samsung BioLogics. And more.

1. SABCS: AstraZeneca, Daiichi's ADC keeps breast cancer at bay for 16 months

AstraZeneca and Daiichi Sankyo’s HER2-targeting antibody-drug conjugate, [fam-] trastuzumab deruxtecan, or DS-8201, showed what Jefferies analysts called “impressive efficacy.” In a phase 2 study, the drug staved off cancer for a median of 16.4 months and shrank tumors in 61% of breast cancer patients who had tried a median of six prior therapies. The estimated one-year survival rate reached 86%. But the drug does pose some safety problems.

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

Janssen and Legend Biotech’s BCMA-targeting CAR-T therapy, JNJ68284528 (known as LCAR-B38M in China), cleared tumors in 69% of patients with advanced multiple myeloma who had previously tried at least three different classes of drugs. In an update of the phase 1/2 Legend-2 trial in China, a year and a half after dosing, the drug kept cancer at bay in 50% of all patients but in 71% of patients who had achieved a complete response.

3. Samsung execs face jail for destroying evidence in Biogen JV fraud probe

Three Samsung Electronics executives face jail terms of up to two years in Korea for destroying data and documents that prosecutors believe are linked to an accounting fraud probe at Samsung BioLogics. The scheme involved replacing the company’s finance team’s computers, deleting log files and hiding a backup server, which prosecutors found under the floor during a raid of a plant.

4. AstraZeneca rounds out stellar China year—and beats Roche to the punch—with Imfinzi lung cancer nod

AstraZeneca's Imfinzi won a go-ahead in China to treat stage 3 non-small cell lung cancer. It's the first approval for an anti-PD-L1 agent in China, with Roche’s Tecentriq following closely behind. The drugmaker has not announced its pricing plan for Imfinzi, but a company spokesperson said it will be “comparable to currently available innovative therapies in China.”

5. FDA greenlights generics of Novartis' $3B MS star Gilenya amid legal fight

The FDA approved the first three generic versions of Novartis’ $3 billion-a-year multiple sclerosis drug Gilenya. They will be made by HEC Pharm, Biocon and Sun Pharma. However, the copycats won’t be able to launch anytime soon because of an ongoing patent protection fight.

6. ASH: BeiGene, eyeing Imbruvica's CLL share, touts more early Brukinsa data

BeiGene rolled out more data for its newly approved BTK inhibitor Brukinsa in chronic lymphocytic leukemia, eyeing AbbVie and Johnson & Johnson’s leading in-class rival Imbruvica. At a median follow-up of 29.5 months, Brukinsa had triggered a response in 118 out of 123—or 95.9%—CLL patients in a phase 1/2 trial.

7. ASH: Takeda details Ninlaro's miss in scrapped AL amyloidosis trial

Takeda’s Ninlaro, plus dexamethasone, induced a response in 53% of patients with the rare disease light-chain amyloidosis in a phase 3 trial. Although that number didn’t significantly top the 51% achieved by a physician’s choice of treatment, Takeda is touting some secondary endpoint wins that execs called “patient-relevant.”

8. Takeda to develop home hemophilia bleeding risk test with Enzyre

Takeda is teaming up with the Dutch testing firm Enzyre to develop an at-home diagnostic device to help people with hemophilia determine their own coagulation status and potentially share results with care providers via a smartphone. The Japanese drugmaker got its hem A franchise through its Shire acquisition.

9. Fujifilm liposome plant ready to deliver

Fujifilm has completed the first manufacturing facility in Japan to make drug-delivering liposomes to use for cancer-fighting drugs, both for itself and for other drug developers. The 4 billion yen ($37.5 million) facility in Tokyo is set to be operational in February 2020.

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