Eli Lilly and Company wins first-line Jaypirca approval for CLL/SLL
The FDA label covers previously untreated adults with no known 17p deletion after a 282-patient trial against chemoimmunotherapy.
Adrian Kessler
A first-line treatment option for adults with CLL or SLL who have no known 17p deletion opened Friday as Eli Lilly and Company NYSELLY said the FDA expanded Jaypirca's U.S. label. In the trial behind the decision, the drug's hazard ratio for progression or death was 0.20 against bendamustine plus rituximab, according to Lilly's Oct. 2 release.
The revised prescribing information authorizes Jaypirca, or pirtobrutinib, for previously untreated adults in that group at 200 mg orally once daily until progression or unacceptable toxicity. The medicine already carried a CLL/SLL indication for adults previously treated with a covalent BTK inhibitor. Patients with a documented 17p deletion are outside the new initial-treatment indication.
Lilly is an Indianapolis drugmaker with oncology medicines alongside its larger metabolic-health portfolio. Jaypirca inhibits Bruton tyrosine kinase, a signalling protein involved in the growth of malignant B cells.
Lilly shares closed lower in New York on Oct. 2. The NYSELLY close was US$1,142.85 at 4:00:05 p.m. EDT.
BRUIN CLL-313 Beat Chemoimmunotherapy
The phase III BRUIN CLL-313 study assigned 141 previously untreated patients to Jaypirca and 141 to bendamustine plus rituximab. It was open-label, while a blinded independent review committee assessed the primary endpoint of progression-free survival. Median follow-up was 28 months.
The trial met that endpoint, with a hazard ratio of 0.20 and a 95 per cent confidence interval of 0.11 to 0.37. The p value was below 0.0001. Median progression-free survival had not been reached for Jaypirca, compared with 33.5 months for the chemoimmunotherapy arm.
Independent reviewers recorded overall responses in 94 per cent of Jaypirca patients and 81 per cent of controls. Complete responses went the other way, at 13 per cent with Jaypirca and 21 per cent with the control regimen. Those response rates are a separate measure from progression-free survival and do not establish how Jaypirca would fare against another BTK inhibitor.
Serious adverse reactions occurred in 28 per cent of Jaypirca recipients, including pneumonia in five per cent; 4.3 per cent stopped the drug permanently because of an adverse reaction. Dose reductions due to adverse reactions affected 3.6 per cent of treated patients. The label also warns about infections, bleeding, low blood counts and heart rhythm problems.
"Doctors can now consider pirtobrutinib for appropriate patients when initial therapy is needed, not just later in a patient's treatment journey," hematologist-oncologist Jennifer A. Woyach said in Lilly's release.
Calquence Has A 14-Cycle First-Line Regimen
AstraZeneca PLC LONAZN NYSEAZN said on Feb. 20 that the FDA approved its Calquence plus venetoclax combination for first-line CLL/SLL. AstraZeneca describes that oral regimen as fixed for 14 cycles, a different treatment schedule from Jaypirca's continuous dosing until progression or unacceptable toxicity.
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Lilly's pivotal comparison was with chemoimmunotherapy, so those Jaypirca results cannot rank it against Calquence. In its Oct. 2 release, Lilly says its separate BRUIN CLL-314 study compares pirtobrutinib with ibrutinib, a covalent BTK inhibitor. That trial includes both previously untreated patients and patients who had received other treatment but no BTK inhibitor. The new label was based on BRUIN CLL-313.
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The iShares Biotechnology ETF NASDAQIBB closed in New York on Oct. 2. Its NASDAQIBB quote showed a US$205.29 close at 4:00:01 p.m. EDT.
Lilly's Oct. 29 third-quarter earnings call is its next dated opportunity to discuss whether the new first-line label has changed Jaypirca prescribing or its commercial outlook.
