In the lead up to Amgen’s second-quarter earnings reveal, Wall Street analysts warned that the company's targeted lung cancer drug Lumakras might disappoint in the U.S. It turns out they were right.
Lumakras brought in $51 million in U.S. sales in the second quarter, only marginally better than the $48 million it generated in the first three months of 2022.
The haul was even worse than what SVB Securities analysts had projected for the first-in-class KRAS inhibitor. After noticing a concerning prescription trend, the SVB team last month estimated Lumakras’ second-quarter U.S. sales would come in at $55 million, below Wall Street consensus of $62.4 million.
For industry watchers, Lumakras’ commercial performance matters not just because it’s the first agent to enter a previously untapped blockbuster non-small cell lung cancer market, but also because it’s one of the growth drivers Amgen is banking on.
The lackluster uptake has a diagnosis bottleneck to thank, Amgen’s commercial chief Murdo Gordon said during an investor call Thursday.
While 85% of U.S. non-small cell lung cancer patients are tested for their KRAS G12C status for potential eligibility for Lumakras, only half of the time do oncologists actually have those test results when patients fail on their initial treatment, Gordon said. Lumakras is approved for KRAS G12C-mutated NSCLC after at least one prior systemic therapy.
The good news is that when the physician does have the KRAS result, 85% of patients go on to receive Lumakras, Gordon said.
The U.S. launch could portend trouble in Europe. Gordon expects a similar uptake pattern in some European countries where biomarker testing and clinical information systems are less developed, including Spain, Italy and the U.K.
Currently, Lumakras is running on an accelerated approval based on tumor shrinkage data. Amgen expects to read out the confirmatory phase 3 trial, CodeBreak 200, by September. A positive readout will make it easier to promote Lumakras, Gordon said.
As the second-line rollout turns out to be slower than expected, Amgen is already eyeing previously untreated patients.
During Thursday’s call, Amgen’s R&D chief Dave Reese sketched out Lumakras’ frontline NSCLC development plan. Amgen will divide Lumakras trials into three large groups potentially by expression levels of the PD-L1 biomarker, Reese said.
Having already seen “promising early data” in the PD-L1-negative population, Amgen will launch a phase 3 study of Lumakras and chemotherapy in first-line advanced or metastatic NSCLC, he said. The Lumakras-chemo combo will be pitted against “what would be considered a standard therapy arm where the addition of checkpoint inhibitors has a relatively modest additive benefit,” the R&D head said, adding that Amgen has had “productive discussions” with the FDA about that trial design.
This all comes as industry watchers and investors are waiting with bated breath Amgen’s release of first data from combinations of Lumakras either with Merck’s PD-1 inhibitor Keytruda or Roche’s PD-L1 blocker Tecentriq this weekend at the World Conference on Lung Cancer annual meeting in Vienna.
A key focus of the readout is the combinability of the two types of agents given real-world reports of worrisome liver toxicities when Lumakras was given to patients who’d already tried a PD-1/L1 drug.
Reese did give a hint of what the data might look like.
“[What] we can say is the PD-1 have been challenging to combine with other targeted agents due to tolerability issues,” he told analysts Thursday.