After years on the back foot, AstraZeneca’s immunotherapy tag team of Imjudo and Imfinzi has pinned down its second indication in less than a month.
The U.S. FDA has signed off on the combo alongside platinum-based chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC), AstraZeneca said Friday. The green light comes right on the heels of Imjudo’s first approval in October—also in tandem with Imfinzi—in unresectable hepatocellular carcinoma, the most common type of liver cancer.
Much like liver cancer—where a melee is already brewing between AZ and Roche, among others—Imjudo’s lung cancer approval portends a struggle with entrenched oncology meds such as Merck's Keytruda, Bristol Myers Squibb's Opdivo and Roche's Tecentriq.
Imjudo’s late-stage NSCLC nod hinges on results from AZ’s phase 3 POSEIDON study, where patients on five cycles of the Imjudo-Imfinzi combo regimen and four cycles of chemotherapy saw their risk of death fall 23% versus “a range of chemotherapy options,” the company said in a release. An estimated 33% of patients on the immunotherapy combo were alive at the study’s two-year mark, compared with 22% of patients in the chemotherapy cohort.
Further, the immunotherapy duo cut the risk of disease progression or death by 28% versus chemotherapy alone, AstraZeneca said.
Lung cancer is the second most common form of cancer in the U.S., with more than 236,000 patients expected to be diagnosed in 2022, AZ estimates. The company points out that prospects for patients with metastatic disease are especially poor, with only about 8% living beyond five years after diagnosis.
Outside the U.S., AZ is waiting on a regulatory verdict for its antibody tag team in places such as Europe and Japan.
Stateside, the regimen will certainly have its work cut out trying to muscle in on the crowded NSCLC market, where Merck’s immuno-oncology juggernaut Keytruda sits comfortably at the top of the field. AZ’s antibody combo will also have to contend with the likes of BMS’ Opdivo and Yervoy, plus chemo, as well as Roche’s Tecentriq, which is approved alone as a front-line treatment in certain NSCLC patients, and in combination with chemotherapy in those without genomic tumor aberrations.
Aside from AZ’s latest Imjudo offerings, other contenders from Regeneron, plus several Chinese firms and their Western collaborators, have threatened to shake up the lucrative NSCLC market. Still, the data from AZ’s combo, or Regeneron's Libtayo-chemotherapy duo, which bagged approval earlier this month, may lack the bite needed to truly challenge Ketruda’s dominance in newly diagnosed disease, SVB Leerink’s immuno-oncology analyst Daina Graybosch, Ph.D., told Fierce Pharma last fall.
For Imjudo-Imfinzi specifically, Graybosch last October speculated that the AZ regimen probably wouldn’t be able to find its niche in front-line NSCLC given its limited improvement in risk of death and a string of previous lung cancer trial flops.