- Roche's checkpoint inhibitor Tecentriq helped extend progression-free survival in a Phase 3 study of patients with a hard-to-treat form of metastatic breast cancer, a milestone the Swiss pharma is painting as a first for the immunotherapy field.
- "IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer (TNBC), an aggressive disease with limited treatment options," said Roche's Chief Medial Officer Sandra Horning in a July 2 statement, noting the drugmaker was "highly encouraged" by the results.
- Data from the study, which pitted Tecentriq plus Abraxane against Abraxane alone, showed a significant reduction in the risk of disease worsening or death in favor of the treatment arm. Roche plans to submit the data to health regulators in hopes of securing approval for the combination.
IMpassion 130 is the fifth positive trial readout for Tecentriq (atezolizumab) so far this year, helping Roche in its bid to compete with immunotherapy leaders Merck & Co and Bristol-Myers Squibb.
Unfortunately for Roche's chances, Merck has solidified its advantage in non-small cell lung cancer with impressive data of its own. Indications like small cell lung cancer or other solid cancer types remain less settled, presenting Roche with opportunities to secure an edge.
Tecentriq's string of clinical successes (with one exception)
|IMpower 131||1L squamous NSCLC||Tecentriq + chemo||Chemo||Positive PFS|
|IMpower 150||1L non squamous NSCLC||Tecentriq + Avastin + chemo||Avastin + chemo||Positive PFS, OS|
|IMblaze 370||2L/3L colorectal cancer||Tecentriq + Cotellic||Stivarga||Miss on OS|
|IMpower 130||1L non squamous NSCLC||Tecentriq + chemo||Chemo||Positive PFS, OS|
|IMpower 133||1L small cell lung cancer||Tecentriq + EP||EP + placebo||Positive PFS, OS|
|IMpassion 130||1L triple-negative breast cancer||Tecentriq + chemo||Chemo + placebo||Positive PFS|
NOTE: Chemo regimens differ. NSCLC = Non-small cell lung cancer, EP = etoposide + platinum-based chemo. SOURCE: Roche, clinicaltrials.gov
Compared to the clinical advances seen in other more immuno-responsive cancer types like lung and skin, cancer immunotherapy has not had much success in breast cancer.
Women with TNBC test negative for expression of hormone receptors or HER2 mutations, making them poor candidates for treatments like Roche's older Herceptin (trastuzumab) that have transformed breast cancer care.
Roughly 15% of all breast cancers are triple-negative, Roche estimates.
In IMpassion 130, the combination of Tecentriq plus Abraxane (nab-paclitaxel) significantly improved median progression-free survival versus Abraxane and placebo in both the overall intent-to-treat study population and those patients who expressed high levels of the PD-L1 biomarker.
At the time of the interim analysis, no statistical difference in overall survival was seen, although results in the PD-L1 positive group were "encouraging," Roche said. This could suggest that the combination has not led to much of a survival benefit across all study participants.
The Swiss pharma is moving ahead quickly, though, indicating plans to soon submit the results to regulators and present at an upcoming medical meeting.
That's important, because Merck could soon be on its heels in TNBC. The rival pharma expects to read out data from two studies of Keytruda (pembrolizumab) in the indication toward the end of this year. One trial is testing Keytruda plus chemo as a neoadjuvant treatment before surgery, while the other is investigating Keytruda alone in second-line or higher treatment settings.
A little further out, results could come in late 2019 from a third Merck study testing Keytruda and chemo in first-line metastatic TNBC — a trial more analogous to IMpassion 130.
"The response rates in triple negative breast cancer are certainly not the best that we've ever seen," said Roger Perlmutter, head of Merck Research Laboratories, in recent comments at an event in April. "But we're hopeful that they'll be sufficient to add benefit for those patients."
Merck also has the advantage of having partial ownership of AstraZeneca's PARP inhibitor Lynparza (olaparib), which has proved effective as a treatment for some breast cancers.
Cowen, an investment firm, predicts Merck and Roche will be the two principal immunotherapy players in TNBC, with Merck predicted to win an upper hand by market share.