5:06 PM
May 15, 2019
 |  BC Extra  |  Clinical News

May 15 ASCO Quick Takes: After-hours pop for Iovance, MacroGenics; plus Takeda, Amgen, Forty Seven

Abstracts were released late Wednesday ahead of the American Society of Clinical Oncology meeting starting May 31 in Chicago. See below for BioCentury's first round of Quick Takes on selected abstracts.

Iovance gains on 44% ORR for LN-145 in cervical cancer 
Iovance Biotherapeutics Inc. (NASDAQ:IOVA) jumped $2.10 (19%) to $13.33 in after-hours trading Wednesday on data from the Phase II innovaTIL-04 trial showing that LN-145 led to an objective response rate (ORR) of 44% among 27 evaluable patients with recurrent, metastatic or persistent cervical carcinoma. The autologous tumor infiltrating lymphocyte (TIL)-based T cell therapy led to one complete response, nine partial responses and two unconfirmed partial responses.

Takeda kinase inhibitor leads to 54% ORR in NSCLC 
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) reported that TAK-788 (AP32788) led to an ORR of 54%, including 14 partial responses, among 26 evaluable previously treated advanced non-small cell lung cancer patients with EGFR exon 20 insertions in a Phase I/II trial. Takeda gained the oral tyrosine kinase inhibitor targeting EGFR and HER2 mutations through its acquisition of Ariad Pharmaceuticals Inc.

Early data for Amgen KRAS inhibitor 
Amgen Inc. (NASDAQ:AMGN) reported early data from a Phase I trial showing that AMG 510 led to one partial response in an NSCLC patient among nine evaluable patients with locally advanced or metastatic solid tumors with KRAS G12C mutations. AMG 510 is a small molecule G12C-mutant KRAS inhibitor. Mirati Therapeutics Inc. (NASDAQ:MRTX) also has a small molecule that selectively targets the G12C mutant form of KRAS, MRTX849, that is in Phase I/II testing to treat advanced solid tumors harboring KRAS G12C mutations.

MacroGenics' margetuximab improves OS by 1.7 months at interim look 
Data from an immature analysis reported by MacroGenics Inc. (NASDAQ:MGNX) showed that margetuximab plus chemotherapy improved median overall survival by 1.7 months compared with Herceptin trastuzumab plus chemotherapy in the Phase III SOPHIA trial to treat HER2-positive metastatic breast cancer. In a prespecified subgroup carrying the CD16a 158F allele, the benefit improved to 6.8 months for the margetuximab arm compared with the Herceptin arm. MacroGenics was up $1.93 (12%) to $18.20 in after-hours trading.

On Feb. 6, MacroGenics gained 130% after the company said margetuximab plus chemotherapy met the first sequential primary endpoint of improving median progression-free survival (PFS) vs. Herceptin plus chemotherapy (5.8 vs. 4.9 months, p=0.033). The company plans to submit a BLA to FDA next half for the Fc optimized mAb against HER2 (see "Big Gain for MacroGenics After Breast Cancer Readout").

First data for Forty Seven’s anti-CD47 antibody 
Forty Seven Inc. (NASDAQ:FTSV) reported the first data for its Hu5F9-G4 (5F9) from a Phase Ib trial of the humanized mAb against CD47 given alone or in combination with azacitidine to treat acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Among 25 evaluable patients, eight (53%) of 15 previously untreated patients had a complete response or CR with incomplete blood count recovery to the combo regiment, and one of ten relapsed/refractory patients achieved a morphologic leukemia-free state after treatment with Hu5F9-G4 alone.

Targets: EGFR (ErbB1; HER1) - Epidermal growth factor receptor; HER2 (EGFR2; ErbB2; neu) - Epidermal growth factor receptor 2; KRAS - K-Ras

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