Newsmakers at #EHA19: Regeneron, ArQule track progress on response rates
Regeneron’s closely-watched bispecific continues to ring up high response rates
Regeneron’s high-profile bispecific REGN1979 is back in the spotlight at the European Hematology Association scientific confab. And while the stellar numbers we saw at ASH have eroded somewhat as more blood cancer patients are evaluated, the response rates for this CD3/CD20 drug remain high.
A total of 13 out of 14 follicular lymphomas responded to the drug, a 93% ORR, down from 100% at the last readout. In 10 out of 14, there was a complete response. In diffuse large B-cell lymphoma the response rate was 57% among patients treated at the 80 mg to 160 mg dose range. They were all complete responses. And 2 of these Cars were for patients who had failed CAR-T therapy.
“(T)here is currently no approved therapy for patients who progress on CAR-Ts,” noted Regeneron’s Israel Lowy. “Our potentially registrational Phase 2 program is initiating this month and will proactively evaluate active REGN1979 doses in indolent and aggressive non-Hodgkin lymphoma.”
Noted Baird’s Brian Skorney:
The follicular lymphoma data don’t look as stellar as the prior data cut but the DLBCL data improve. We think this bispecific program looks like a strong next-gen B-cell lymphoma therapy that could yield a fairly significant market opportunity.
ArQule rights the ship with more proof-of-concept data
After a less than flattering showing at the last EHA, ArQule is returning triumphant.
Homing in on the BTK-C481AS mutation, ArQule highlighted data from a cohort of six chronic lymphocytic leukemia patients who have either not responded to treatment or relapsed. Having received the 65 mg dose, four of them experienced a partial response — a significant feat given they have already exhausted available therapies, the company said. Shares $ARQL surged 47% pre-market to $9.26.
“We are now focused on finalizing the recommended phase 2 dose and planning for the expansion of our clinical efforts with ARQ 531 into later stage trials across multiple indications as a single agent and as a combination therapy,” CMO Brian Schwartz said in a prepared statement.
In addition, investigators also noted a partial response for a patient with Richter’s Transformation who had progressed on ibrutinib and R-CHOP.
Little Oryzon shows it’s doing alright with AML drug on its own
Oryzon has seen the first glimpse of efficacy data for its LSD1 inhibitor, iadademstat when combined with chemotherapy in elderly patients with acute myeloid leukemia. Clinical responses were observed rapidly with a median time of 1.5 months, and of the 5 evaluable patients, 3 achieved complete remissions (albeit with incomplete hematologic recovery) while 1 had a partial remission.
The trial is being conducted in Spain, where Oryzon was founded. The company plans to recruit up to 36 patients to set the stage for the broader application of iadademstat — once partnered but later dumped by Roche — in other leukemias.
BerGenBio spotlights AML drug’s potential in patients unfit for intense chemo
Norway’s BerGenBio is spotlighting 6 responses out of 14 evaluable patients on its drug, which is designed to pair with low-intensity chemotherapy for acute myeloid leukemia patients who cannot stand intense chemotherapy. Their AXL inhibitor bemcentinib helped push 4 patients into complete remission (with or without incomplete hematologic recovery) and 2 others into partial remission.
“Bemcentinib in combination with LDAC resulted in a substantially higher ORR than expected for single-agent cytarabine and clearly warrant further investigation of bemcentinib in an expansion cohort of AML patients unfit for intensive chemotherapy,” professor Bjørn Tore Gjertsen of Haukeland University Hospital and the University of Bergen said. “Our signal cell-level biomarker analysis of AML blasts from patients indicates a substantial effect on cell signaling and represents a potential new biomarker strategy.”