Roche preps filings for Tecentriq in early TNBC after trial win

Roche has scored a major win with its checkpoint inhibitor Tecentriq as a pre-surgery treatment for triple-negative breast cancer (TNBC), extending its lead over rival drugs in this aggressive disease.

Tecentriq (atezolizumab) is the first and only PD-1/PD-L1 inhibitor to be approved for TNBC, getting a green light last year in combination with Bristol-Myers Squibb’s Abraxane (nab-paclitaxel) chemotherapy in women with advanced, PD-L1-positive TNBC who can’t be treated with surgery.

The new IMpassion031 trial results could extend its use into a much larger indication: as a neoadjuvant (pre-surgery) treatment for women with early-stage TNBC, regardless of their PD-L1 status, to reduce the chances of the cancer coming back.

So far, none of the checkpoint inhibitors have been approved for neoadjuvant or adjuvant (post-surgery) use in any cancer type, so Roche is treading new ground for the class with Tecentriq. The company says it will now discuss the findings with regulators in the US and Europe.

Impassion031 compared Tecentriq and Abraxane or placebo in the neoadjuvant setting, followed by standard chemo with doxorubicin and cyclophosphamide. The main endpoint was the pathological complete response (pCR) – in other words, the proportion of patients with no evidence of residual cancer at the time of surgery.

Fewer patients who received the Tecentriq combination had detectable tumour tissue detectable at the time of surgery than the control group, according to Roche, although the actual data haven’t yet been revealed.

The company’s chief medical officer Levi Garraway said that TMBC “remains an aggressive disease with high rates of recurrence”, adding “our goal in treating TNBC at its earliest stages is to provide people with the best chance for a future cure”.

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working and may also reduce a tumour's size so it is easier to surgically remove. An earlier trial of neoadjuvant Tecentriq in early, high-risk TNBC – called NeoTRIP – failed to show an improvement with Roche’s drug on pCR.

TNBC has been one of the indications driving sales growth for Tecentriq since the new indication was approved by the FDA last year on the strength of the Impassion130 trial, although updated findings from the trial published last November found no statistically significant improvement in overall survival with the drug.

All told, Tecentriq brought in around $2bn for Roche last year across its approved uses in TNBC, bladder and various forms of non-small cell and small cell lung cancer.

Roche is also looking at neoadjuvant use of Tecentriq in other tumour types, including bladder cancer with IMvigor010, but that generated negative results.