Amgen’s Lumakras and AstraZeneca’s Calquence are both in line to expand their respective oncology reaches with new FDA approvals.
Calquence, in combination with chemotherapy bendamustine and Roche’s Rituxan, can now treat patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
The FDA based its decision on the ECHO phase 3 study, which had an earlier-than-anticipated readout in May. In the trial, Calquence plus bendamustine and Rituxan reduced the risk of disease progression or death by 27% compared with standard-of-care chemotherapy, helping patients live longer without their disease getting worse for a median of 66.4 months, over chemo’s 49.6 months. The same trend was observed when taking out instances of COVID-19-related fatalities, as the trial enrolled over the pandemic.
“This approval brings a new and effective treatment option to those living with this disease and further reinforces our belief in Calquence as a backbone therapy across multiple blood cancers,” Dave Fredrickson, executive vice president of AZ’s oncology hematology business unit, said in a company announcement Friday.
The latest nod converts the FDA’s previously granted accelerated approval for MCL patients treated with at least one prior therapy to a full one and adds to Calquence’s breadth of worldwide approvals across cancer types including chronic lymphocytic leukemia and small lymphocytic lymphoma.
AZ is also evaluating the treatment in several B-cell blood cancers such as diffuse large B-cell lymphoma, among others. The drug is a significant sales (PDF) driver within the company’s oncology portfolio, bringing in $2.3 billion over the first nine months of 2024 and $813 million during the third quarter.
As for Amgen, the company’s Lumakras and Vectibix combination was granted approval to treat patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) who have received prior fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy. In the company’s phase 3 CodeBreak 300 study, the combo proved itself as the first to trump investigated standard of care on the progression-free survival marker, Amgen said in a press release Friday.
"Lumakras plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care,” said Jay Bradner, M.D., Amgen’s executive vice president of R&D.
More specifically, the Lumakras combo made for a median progression-free survival of 5.6 months, compared to 2 months on the investigator’s choice of care (Taiho Oncology’s Lonsurf or Bayer’s Stivarga). Amgen’s offering also proved an overall response rate of 26% over 0% in the investigator’s choice arm. However, the final analysis of the overall survival endpoint was not statistically significant.
Amgen’s Lumakras has an accelerated approval for those with KRAS G12C-mutated non-small cell lung cancer and has until 2028 to complete a study to support full approval—a new deadline after the company’s bid to convert the approval was rejected in 2023. Vectibix, meanwhile, was first approved back in 2006.
Lumakras picked up $98 million in third quarter sales for Amgen, representing 88% year-over-year growth.