AstraZeneca Elated On Calquence Data, IMGN's IMGN632 Appears To Be Promising In AML, XRTX On Watch

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Today's Daily Dose brings you news about AstraZeneca's new long-term data related to cancer drug Calquence; superior efficacy of Novartis' Scemblix compared to Bosulif in chronic myeloid leukemia; and ImmunoGen's updated initial safety and efficacy findings from its phase 1b/2 study of IMGN632 in combination with Vidaza and Venclexta in patients with relapsed/refractory acute myeloid leukemia, to name a few.

Read on…

1. AstraZeneca's New Findings ELEVATE Calquence

AstraZeneca PLC (AZN) has reported impressive new long-term data related to its approved cancer drug Calquence from its ASCEND and ELEVATE-RR trials.

ASCEND is a phase III trial that evaluated the efficacy and safety of Calquence (100mg twice-daily until disease progression or unacceptable toxicity) versus chemotherapy drugs like Idelalisib (sold under the brand name Zydelig) Bendamustine (Treanda) relapsed or refractory chronic lymphocytic leukemia.

In the ASCEND trial, at three years, Calquence reduced the risk of disease progression or death by 71% compared to standard of care combinations in relapsed or refractory chronic lymphocytic leukemia patients.

The ELEVATE-RR trial is a phase III non-inferiority trial of Calquence versus AbbVie's approved drug Ibrutinib (Imbruvica) in patients with relapsed or refractory CLL after at least one prior therapy. In this study, overall, patients on Ibrutinib experienced a 37% higher burden of adverse events of any grade versus patients on Calquence.

Calquence was approved by the FDA for the treatment of mantle cell lymphoma in 2017 and for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma in 2019. The drug generated global sales of $843 million in the first nine months of 2021, up 148% over the year-ago period.

AZN closed Friday's trading at $54.02, down 1.71%.

2. Novartis' Scemblix Demonstrates Superiority Over Pfizer's Bosulif

Novartis AG's (NVS) approved drug for chronic myeloid leukemia Scemblix continues to demonstrate superior efficacy and lower discontinuation rate due to adverse reactions compared to Pfizer's Bosulif in a phase III trial, dubbed ASCEMBL.

According to the trial data, the major molecular response (MMR) rate at 48 weeks was 29.3% for patients treated with Scemblix compared to 13.2% for patients in the *Bosulif arm, which is consistent with a doubling of the efficacy at 24 weeks. The proportion of patients treated with Scemblix who experienced adverse reactions leading to discontinuation was more than three times lower than those in the Bosulif arm (7.1% vs. 25%). Bosulif is Pfizer's approved drug for chronic myeloid leukemia.

Data support longer-term use of Scemblix in patients with chronic myeloid leukemia (CML) who have previously struggled with intolerance and resistance to at least two prior tyrosine kinase inhibitor treatments, the company noted.

NVS closed Friday's trading at $80.67, up 0.29%.

3. ImmunoGen Reports Promising Data On IMGN632 In AML

ImmunoGen Inc.'s (IMGN) updated initial safety and efficacy findings from its phase 1b/2 study of IMGN632 in combination with Vidaza and Venclexta in patients with relapsed/refractory acute myeloid leukemia have been found to be promising.

According to the results, IMGN632 in combination with Vidaza and Venclexta demonstrated an objective response rate (ORR) of 48%, with a composite complete remission (CCR) rate of 30%. IMGN632 continued to display a manageable safety profile in R/R AML patients.

Commenting on the data, Naval Daver, Associate Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, said, "Together, the observed anti-leukemia activity and tolerability of IMGN632 in the relapsed/refractory setting are compelling and support the continued evaluation of this triplet in AML patients. I look forward to the next steps for IMGN632 in combination with azacitidine and venetoclax, with preparations for Phase 2 expansion cohorts already underway in both the relapsed and frontline AML settings."

IMGN closed Friday's trading at $6.68, down 2.77%.

4. Xencor To Incorporate subcutaneous administration In Phase I Plamotamab Study

Xencor Inc's (XNCR) updated data from its Phase 1 dose-escalation study of intravenous administration of Plamotamab in patients with B-cell non-Hodgkin lymphomas has demonstrated encouraging clinical activity in heavily pretreated patients.

The efficacy analysis of 47 evaluable patients in the trial has revealed an objective response rate of 51% and complete response rate of 26%, according to the company.

The company plans to incorporate subcutaneous administration into its ongoing Phase 1 monotherapy study of Plamotamab next year.

XNCR closed Friday's trading at $33.79, down 1.11%.

5. COVID-19 Study Supports XORTX Therapeutics' Provisional Patent Filings

The results of a study conducted by XORTX Therapeutics Inc. (XRTX) in partnership with the Ichan School of Medicine have been published in a peer reviewed paper.

The study focused on the clinical outcomes of 834 patients with COVID-19 infection who were hospitalized at Mount Sinai Hospital in New York City, especially the potential predictive role of serum uric acid on clinical outcomes.

Richard Johnson, a Professor at the University of Colorado and an author on the study, said, "An elevated serum uric acid has been found to be a risk factor for acute kidney injury in other studies, such as following cardiovascular surgery. This, however, is the first paper to my knowledge that has shown that a high uric acid is common in subjects with COVID and predicts both the development of kidney damage and mortality."

Allen Davidoff, CEO of XORTX added, "The results of this study support the company's provisional patent filings in March 2020 and 2021 that contain claims to the use of any uric acid lowering agents to prevent and treat acute kidney, acute organ injury or sepsis associated with COVID-19 infection. Resulting from this study is a more fulsome understanding that measurement of uric acid at the time of hospitalization, rapid uric acid lowering in patients who show evidence of acute kidney injury plus hyperuricemia may improve outcomes in hospitalized patients."

XORTX Therapeutics is a pharmaceutical company developing drug-based therapies for serious progressive kidney diseases.

The company has 3 drug candidates in its pipeline - XRx-008; XRx-101; and XRx-225.

-- XRx-008 for Autosomal Dominant Polycystic Kidney Disease is preparing to enter phase III testing in 2022.
-- XRx-101 is being developed for the treatment of acute kidney and lung injury accompanying coronavirus infection and specifically for the COVID-19 infection.
-- XRx-225 for Type 2 Diabetic Nephropathy is under preclinical development.

XRTX closed Friday's trading at $2.20, down 6.38%.

6. New Highs/Lows

Centene Corporation (CNC) closed at a new high of $78.45, up 4.78%.
CVS Health Corp. (CVS) closed at a 5-year high of $98.86, up 1.59%.
AbbVie Inc. (ABBV) closed at a new high of $125.47, up 1.06%.
Angion Biomedica Corp. (ANGN) closed at a new low of $2.61, down 25.21%.
Vaccitech plc (VACC) closed at a new low of $9.76, down 18.12%.

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