Results

#ASCO17 highlights: Roche ushers early-stage bispecific into view; Agios, Celgene unveil more AG-221 data; Plenty more coming at ASCO

Roche has an early-stage T cell bispecific — which binds simultaneously to T cells and tumor cells — called CEA-TCB (RO6958688; RG7802) that it is bullish about. It released a very early look at Phase I data for ASCO, looking at monotherapy as well as a combo with its checkpoint Tecentriq. The data demonstrate: “In the monotherapy, out of 31 patients with mCRC treated with CEA-TCB doses of 60mg or above, 14 patients (45%) showed either partial response (n=2, 6%) or stable disease (n=12, 39%). For the combination, of 25 patients treated with doses of 5–160mg of CEA-TCB, 11 patients with MSS mCRC were treated at doses shown to induce tumour lesion inflammation (80 and 160 mg). Nine of these patients (82%) showed either a partial response (n=2, 18%) or stable disease (n=7, 64%) in this difficult-to-treat population.”

Agios and Celgene delve deeper into AG-221 data

Agios and its big partner Celgene have already filed for an approval of AG-221, which they now prefer to call enasidenib. Presumably we’ll get a better look at its data — and its prospects — at the conference. In the meantime it offers an update on their Phase I dose escalation study:

For R/R AML pts, overall response rate (ORR) was 40.3%, including 34 (19.3%) complete remissions (CR; Table). Response was associated with cellular differentiation, typically with no evidence of aplasia. Median overall survival (OS) for R/R AML pts was 9.3 months (mos). For pts who attained CR, OS was 19.7 mos. Pts who had received ≥2 prior AML regimens (n=94; 53%) had median OS of 8.0 mos.

So far, so good.

A snapshot of Five Prime’s cabiralizumab data

Michael Schmidt at Leerink offered this quick look at Phase I/II data from Five Prime’s cabiralizumab. He noted:

Recall, this study advanced into Phase II in May 2016 and in April 2017 enrollment of 30 PVNS patients completed. Abstract #11078 highlights activity at the 4mg/kg dose (that was chosen for Phase II) with 1 partial response (PR) seen in 3 patients in the Phase I portion of the study. One patient discontinued based on trial rues following creatine kinase (CK) elevation, an asymptomatic laboratory anomaly and on-target effect of macrophage inhibition. In the Phase II portion, FPRX reported 4 PRs in 7 evaluable patients. Another 6 patients in the Phase II portion have received treatment but were not evaluable at time of abstract submission. Positive functional status improvements were also noted in objective responders. Management previously emphasized the importance of quality of life and function improvements (e.g., pain) for PVNS patients.

The good stuff is being held back for ASCO

You’re going to have to wait for ASCO for a lot of things, including more mature data on bluebird bio’s anti-BCMA CAR-T bb2121 Phase I relapsed/refractory multiple myeloma study.


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RAPS Regulatory Convergence 2017