I Today’s 9/30/19 CLRB stock price says
that the weekend’s European presentation was “underwhelming” as compared to expectations.
Now I need to wait and see how TWO IV doses at higher CLR 131 levels in the Phase 2 Clover study helps DLBCL patients as distinguished from these results revealed over the weekend:
“...The oral presentation, entitled: “Interim Evaluation of a Targeted Radiotherapeutic, CLR 131, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients (R/R DLBCL),” featured data from 6 subjects who received a single 30-minute intravenous (IV) dose of 25mCi/m2 of CLR 131. Data showed durable responses, including a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and a 50% clinical benefit rate (CBR). All patients enrolled in the study received an average of 3 prior lines of systemic therapy, 5 of 6 patients were refractory to at least one prior line of therapy. Importantly, CLR 131 showed activity against both germinal center and activated DLBCL. In a patient for whom cytogenetics was available, CLR 131 showed activity against c-Myc and BCL-2 mutation (single & dual-hit) positive patients. As required by the Lugano Criteria for Response, the patient who experienced a CR had a total reduction in tumor volume of greater than 99% and continues to be a CR at 510+ days post dosing. This patient was refractory to two prior treatment lines, which included the combination regimen RICE.
Analysis of dosing showed that the disease control rate and progression free survival were markedly improved in patients receiving a dosing ratio of 1.2% or greater (drug to tumor volume) versus those receiving below a 1.2% dosing ratio. Finally, the most frequent adverse events (AE) in DLBCL patients were consistent with prior studies of CLR 131; the majority of AEs being hematologic in nature and predominately Grades 1 and 2.
“The data presented show an encouraging overall response rate including a complete response at the time of the interim assessment after a single 30-minute IV dose of 25mCi/m2 of CLR 131. We remain optimistic that CLR 131 has the potential to provide a meaningful treatment option for a variety of lymphoma patients and look forward to reporting additional data from this Phase 2 CLOVER-1 study in 2019,” said James Caruso, president and CEO of Cellectar. “The study remains ongoing and, based on this cohort and additional data from an ongoing dose escalation Phase 1 study, patients in the Phase 2 CLOVER-1 study are now receiving a higher 37.50 mCi/m2 fractionated dose administered in two 30-minute infusions of 18.75mCi/m2.”
CLRB NEEDS A MUCH HIGHER OVER ALL RESPONSE RATE (ORR), AGAINST ALL THE CANCER TYPES, OR A FEW OF THEM, BEFORE THE STOCK PRICE CAN HIT $5+ or $10+ price per share AND PATIENTS CAN TRULY BENEFIT!
TO BE CLEAR, AN ORR OF OVER 50% will be needed! I prefer 75%.
