Roche (RHHBY) Announces Data on Tecentriq Combo for HCC

RHHBY NVO LGND

Roche (RHHBY - Free Report) announced encouraging data from the phase III IMbrave050 study.

IMbrave050 is a late-stage global, multi-center, open-label, randomized study evaluating the efficacy and safety of adjuvant Tecentriq (atezolizumab) plus Avastin (bevacizumab) compared with active surveillance in people with hepatocellular carcinoma (HCC) at high risk of recurrence (determined by the size and number of cancerous lesions and the histopathology results, if available) after surgical resection or ablation with curative intent.

The study randomized 668 people with a ratio of 1:1 to receive either cancer immunotherapy Tecentriq (1,200 mg every three weeks) plus Avastin (15 mg/kg every three weeks) for a period of 12 months or 17 cycles or no intervention with active surveillance. The primary end-point is independent review facility-assessed recurrence-free survival (RFS).

Data showed that Tecentriq plus Avastin demonstrated a statistically significant improvement in RFS in HCC patients at high risk of disease recurrence following liver resection or ablation with curative intent.

The combination reduced the risk of cancer returning by 28%, compared with active surveillance, at a median follow-up of 17.4 months. Data for overall survival (OS), a key secondary end-point, was immature at the time of data analysis. The safety data for Tecentriq plus Avastin was consistent with the well-established safety profile of each treatment and with the underlying disease.

Per the press release, four of five people with HCC who received surgery with curative intent may see their cancer return, indicating an urgent need for adjuvant treatments to prevent early recurrence and improve survival rates.

Roche is in discussions with health authorities and follow-up will continue for the final RFS data and more mature OS data at the next planned analysis.

Tecentriq is approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and HCC. It is also approved either alone or in combination with targeted therapies and/or chemotherapies for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

The Roche stock has lost 24.7% in the past year against the industry’s growth of 8.6%.

 

 

Roche’s performance in 2022 was average, as the demand for COVID-19 products declined significantly, even though the diagnostics base business and newer drugs maintained their growth.

New drugs, namely Ocrevus, Hemlibra, Evrysdi and Tecentriq, recorded growth and the uptake of the new eye drug Vabysmo (launched at the beginning of 2022) was outstanding. This momentum should continue in 2023. The company is scheduled to provide a first-quarter sales update on Apr 26.

Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some other top-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.

In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have moved up by 29 cents to $5.19.

Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed in the remaining three.

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