A yr and a half after getting its next-gen BTK inhibitor approved in chronic lymphocytic leukemia (CLL), AstraZeneca is again with long-term data that suggest the drug stands a combating probability towards J&J and AbbVie’s first generation blockbuster Imbruvica.
At a median follow-up of 40.9 months, Calquence matched Imbruvica for a median professionalgression-free survival of 38.4 months in patients who had previously been deal withed for CLL, AstraZeneca announced at ASCO. However when it got here to automotivediac occasions, Calquence finested its lengthystanding rival, with a 9.4% incidence of all-grade atrial fibrillation, compared to a 16% fee within the Imbruvica arm (p= 0.02). Atrial fibrillation is an irregular coronary heartbeat that may result in stroke or coronary heart failure.
The information comes — which comes as AstraZeneca struggles in vaccines — represents another win in Pascal Soriot’s effort to establish the company as a frontrunner in oncology.
“Automotivediac advertverse occasions are an important consideration for deal withing chronic lymphocytic leukemia patients with Bruton’s tyrosine kinase inhibitors betrigger they’ll professionalduce significant morbidity in some cases and also lead patients to discontinue deal withment,” John Byrd, lead investigator of AstraZeneca’s ELEVATE-RR trial, mentioned in a statement.
CLL is probably the most common kind of leukemia in adults, with greater than 21,000 new cases reported within the US to date this yr. In patients with the disease, too many blood stem cells within the bone marrow become abnormal lymphocytes, which have difficulty combating infections. Because the number of abnormal cells grows, there’s much less room for wholesome white and purple blood cells and platelets, AstraZeneca mentioned.
Calquence was approved for CLL again in November 2019, each as a monotherapy in second-line patients and as a combination deal withment with Roche’s Gazyva in entranceline patients. However the Elevate-RR trial is the primary to compare the 2 BTK inhibitors head-to-head in CLL, and may assist AstraZeneca carve out an area within the market.
Calquence bagged $522 million in gross sales final yr, compared to Imbruvica’s global gross sales of $5.3 billion.
Elevate-RR enrolled 533 patients with a type of CLL that doesn’t respond to deal withments like chemotherapy. In advertdition to lower incidence of atrial fibrillation, AstraZeneca says these within the Calquence arm also noticed a much lesser frequency of other aspect effects, including bleeding occasions, hypertension and infections.
“The securety and tolerability of Calquence in Elevate-RR was consistent with the recognized professionalfile of Calquence,” the company mentioned in a statement.
Within the Calquence arm, advertverse occasions led 14.7% of patients to discontinue the deal withment, versus 21.3% of patients within the Imbruvica arm. All-grade automotivediac occasions have been seen in 24.1% of Calquence patients and 30% of Imbruvica patients. All-grade bleeding occasions have been documented in 38% of Calquence patients versus 51.3% of Imbruvica patients. Hypertension was seen in 9.4% and 23.2% of patients within the respective arms. And all-grade infections have been seen in 78.2% versus 81.4% of the patients.
However, a larger number of patients within the Calquence arm experienced second primary malignancies excluding non-melanoma pores and skin cancer (9% versus 7.6% within the Imbruvica arm).
AstraZeneca also learn out four-year data from its Section III Elevate-TN trial, through which Calquence “continued to indicate a powerful PFS benematch” as a combination therapy or monotherapy in previously undeal withed CLL patients, the company mentioned.
After a median follow-up of 46.9 months, Calquence and Gazyva reduced patients’ danger of disease professionalgression or dying by 90% compared to Gazvya and the chemotherapy chlorambucil, AstraZeneca mentioned. As a monotherapy, Calquence reduced the danger of disease professionalgression or dying by 81%, actwineing to the data. Median professionalgression-free survival wasn’t met in either arm on the four-year follow-up.
Actwineing to AstraZeneca, estimated PFS charges for the combination therapy and monotherapy are 87% and 78%, respectively, compared to 25% for chlorambucil plus Gazyva.
“Tolerability is a critical factor in deal withing patients with chronic lymphocytic leukemia who often remajor on medicines for a few years and experience multiple comorbidities,” Dave Fredrickson, executive VP of AstraZeneca’s oncology business unit, mentioned in a statement.
Calquence and Imbruvica might quickly have some new competitors, including BeiGene’s Brukinsa, which demonstrated a “statistically significant lower danger of atrial fibrillation or flutter” in a head-to-head trial with Imbruvica again in April. And again in December, Eli Lilly mentioned it will however its personal BTK inhibitor LOXO-305 towards Imbruvica in two head-to-head studies.