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Roche's Tecentriq Plus Chemo Gets FDA Priority Tag for Colon Cancer
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Key Takeaways
RHHBY's FDA filing seeks expanded Tecentriq use with FOLFOX6 after surgery in stage III colon cancer.
Phase III ATOMIC showed a 50% lower risk of recurrence or death versus FOLFOX6 alone.
Roche reported 86% disease-free survival at 36 months with Tecentriq plus FOLFOX6 treatment.
Roche (RHHBY - Free Report) announced that the FDA has granted priority review to its supplemental biologics license application (sBLA), seeking approval for expanded use of adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), in combination with FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil and oxaliplatin).
The therapy is intended to serve as the adjuvant treatment for patients with stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer.
The regulatory authority has set a target action date of Oct. 9, 2026. If approved, Tecentriq plus chemotherapy would be the first immunotherapy-based adjuvant option for patients with stage III dMMR/MSI-H colon cancer after surgery.
A Priority Review designation means the FDA’s goal is to take action on an application within six months compared with 10 months under standard review.
Year to date, Roche shares have lost 2.2% against the industry’s 4.8% growth.
Image Source: Zacks Investment Research
Tecentriq is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. The drug is approved in several countries either alone or in combination with targeted therapies and chemotherapies for several cancers.
RHHBY’s sBLA for Tecentriq Based on Phase III ATOMIC Study
The sBLA is supported by data from the phase III ATOMIC study evaluating Tecentriq plus FOLFOX6 versus FOLFOX6 alone in patients with stage III dMMR colon cancer. The study demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% versus FOLFOX6 alone in patients. At 36 months, disease-free survival was 86% in the Tecentriq-plus-FOLFOX6 arm compared with 76% for chemotherapy alone. The combination's safety profile was consistent with the known profiles of Tecentriq and FOLFOX6.
Per Roche, more than one million people worldwide are diagnosed with colon cancer each year, making it one of the most common and deadly cancers. Despite surgery and chemotherapy, about 30% of stage III patients relapse within five years. Approximately 15% of patients have dMMR/MSI-H tumors, a subtype characterized by high mutation rates that may respond well to immunotherapy.
Roche is pursuing additional regulatory filings, including in Europe to expand access to this potential first immunotherapy-based adjuvant treatment for patients with stage III dMMR/MSI-H colon cancer worldwide.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 6.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.94. Over the same period, EPS estimates for 2027 have risen to $4.81 from $3.79. LQDA shares have gained 89.2% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, earnings per share estimates for Immunocore’s 2026 remained unchanged at 6 cents for 2026 and 87 cents for 2027. IMCR shares have lost 19.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
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Roche's Tecentriq Plus Chemo Gets FDA Priority Tag for Colon Cancer
Key Takeaways
Roche (RHHBY - Free Report) announced that the FDA has granted priority review to its supplemental biologics license application (sBLA), seeking approval for expanded use of adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), in combination with FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil and oxaliplatin).
The therapy is intended to serve as the adjuvant treatment for patients with stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer.
The regulatory authority has set a target action date of Oct. 9, 2026. If approved, Tecentriq plus chemotherapy would be the first immunotherapy-based adjuvant option for patients with stage III dMMR/MSI-H colon cancer after surgery.
A Priority Review designation means the FDA’s goal is to take action on an application within six months compared with 10 months under standard review.
Year to date, Roche shares have lost 2.2% against the industry’s 4.8% growth.
Image Source: Zacks Investment Research
Tecentriq is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. The drug is approved in several countries either alone or in combination with targeted therapies and chemotherapies for several cancers.
RHHBY’s sBLA for Tecentriq Based on Phase III ATOMIC Study
The sBLA is supported by data from the phase III ATOMIC study evaluating Tecentriq plus FOLFOX6 versus FOLFOX6 alone in patients with stage III dMMR colon cancer. The study demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% versus FOLFOX6 alone in patients. At 36 months, disease-free survival was 86% in the Tecentriq-plus-FOLFOX6 arm compared with 76% for chemotherapy alone. The combination's safety profile was consistent with the known profiles of Tecentriq and FOLFOX6.
Per Roche, more than one million people worldwide are diagnosed with colon cancer each year, making it one of the most common and deadly cancers. Despite surgery and chemotherapy, about 30% of stage III patients relapse within five years. Approximately 15% of patients have dMMR/MSI-H tumors, a subtype characterized by high mutation rates that may respond well to immunotherapy.
Roche is pursuing additional regulatory filings, including in Europe to expand access to this potential first immunotherapy-based adjuvant treatment for patients with stage III dMMR/MSI-H colon cancer worldwide.
RHHBY’s Zacks Rank & Other Stocks to Consider
Roche currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 6.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.94. Over the same period, EPS estimates for 2027 have risen to $4.81 from $3.79. LQDA shares have gained 89.2% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, earnings per share estimates for Immunocore’s 2026 remained unchanged at 6 cents for 2026 and 87 cents for 2027. IMCR shares have lost 19.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.