TECENTRIQ + bevacizumab:                  NOW APPROVED                                    in 1L unresectable HCC

THE STRENGTH OF SUPERIOR SURVIVAL  

For over a decade, systemic therapy
for 1L HCC has shown poor survival
benefit and decreased patient QoL.
TECENTRIQ + bevacizumab,

the first cancer immunotherapy combination in 1L unresectable HCC is revolutionising the treatment paradigm and bringing new hope to patients.1-4

HCC IS AN AGGRESSIVE CANCER WITH
LIMITED SYSTEMIC TREATMENT OPTIONS5

HCC is the 4th leading cause of cancer deaths worldwide6;
less than half of patients with unresectable HCC are still alive
1 year after diagnosis.7

TECENTRIQ + bevacizumab:
THE FIRST CANCER IMMUNOTHERAPY COMBINATION IN 1L                      UNRESECTABLE HCC4

A young female healthcare practitioner smiles kindly at a male patient.

THE DEVELOPMENT OF TECENTRIQ IS BASED ON AN
EXTENSIVE CLINICAL PROGRAMME ADDRESSING KEY UNMET
MEDICAL NEEDS ACROSS DIFFERENT TUMOUR TYPES.

 

TECENTRIQ INDICATIONS

TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.1

IMbrave150: first positive, phase III trial of cancer immunotherapy combination vs sorafenib in 1L unresectable HCC4

A global, open-label, Phase III, randomized trial in patients with previously untreated unresectable HCC 4

IMbrave150: updated efficacy analysis8

Unprecedented survival in 1L unresectable HCC patients8

 

Significant OS benefit with 34% reduction in risk of death with TECENTRIQ + bevacizumab vs sorafenib8

  • dddd

    Significantly improved progression-free survival in 1L unresectable HCC4,8

    TECENTRIQ + bevacizumab demonstrated a 35% reduction in disease progression or death vs sorafenib8

    Clinical cutoff: August 31, 2020; median follow-up: 15.6 months 

    a: Stratification factors included in the Cox model are geographic region (Asia excluding Japan vs Rest of World), AFP level (< 400 ng/mL vs ≥ 400 ng/mL) at baseline and MVI and/or EHS (Yes vs No) per interactive voice/web response system (IxRS).

    b: P value for descriptive purposes only.

  • dddd

    Increased benefit in overall response rate vs sorafenib in 1L unresectable HCC patients4,8

    TECENTRIQ + bevacizumab reduced tumour burden vs sorafenib and have demonstrated complete responses in 8% of patients compared to 0,6% with sorafenib8

    ORR as assessed by HCC mRECIST was 35,4% with TECENTRIQ + bevacizumab (n=115/325; 95% CI, 20, 41) vs 13% with sorafenib (n=22/165; 95% CI, 9, 20)

    – CR: 12% vs 3%              
    – PR: 23% vs 11%
     
    At the time of analysis, CCOD: 31 August 2020 median DoR was 18,1 months with TECENTRIQ + bevacizumab (95% CI, 2,5- 25,6) vs 14.9 months with sorafenib (95% CI, 2.5 - 21.8)

    1L=first line; CI=confidence interval; CR=complete response; DoR=duration of response; HCC mRECIST=hepatocellular carcinoma modified Response Evaluation Criteria In Solid Tumors; IRF=independent review facility;
    ORR=overall response rate; PR=partial response; RECIST=Response Evaluation Criteria In Solid Tumors.

    *Assessed by IRF per RECIST v1.1.

    Censored

IMbrave150 primary analysis results1,4

  • dddd

    IMbrave150 primary efficacy analysis: overall survival4

    Significant reduced risk of death demonstrated with TECENTRIQ + bevacizumab vs sorafenib4

    1L=first line; CI=confidence interval; HR=hazard ratio; NE=not estimable; OS=overall survival.

     

    Median OS was a coprimary endpoint

  • dddd

    Significantly improved progression-free survival in 1L unresectable HCC

    TECENTRIQ + bevacizumab demonstrated a 41% reduction in disease progression or death vs sorafenib1

    1L=first line; CI=confidence interval; HR=hazard ratio; PFS=progression-free survival; RECIST=Response Evaluation Criteria In Solid Tumors.

     

    Median PFS as assessed by IRF per RECIST v1.1 was a coprimary endpoint

  • dddd

    More than double the overall response rate vs sorafenib in 1L unresectable HCC

    TECENTRIQ + bevacizumab reduced tumour burden vs sorafenib and have demonstrated complete responses in 7% of
    patients compared to 0% with sorafenib1

    ORR as assessed by HCC mRECIST was 33% with TECENTRIQ + bevacizumab (n=112/336; 95% CI, 28, 39) vs 13% with sorafenib (n=21/165; 95% CI, 8, 19)†

    – CR: 11% vs 1.8%               

    – PR: 22% vs 11%

     

    At the time of analysis, median DoR was not yet reached with TECENTRIQ + bevacizumab (95% CI, NE, NE; range: 1.3+, 13.4+ mo) vs 6.3 months with sorafenib 

    (95% CI, 4.7, NE; range: 1.4+, 9.1+ mo)*†

     

    1L=first line; CI=confidence interval; CR=complete response; DoR=duration of response; HCC mRECIST=hepatocellular carcinoma modified Response Evaluation Criteria In Solid Tumors; IRF=independent review facility; ORR=overall response rate; PR=partial response; RECIST=Response Evaluation Criteria In Solid Tumors.

    *Assessed by IRF per RECIST v1.1. 

    †Confirmed responses.

TECENTRIQ + bevacizumab:
SUPERIOR SURVIVAL AND
ESTABLISHED SAFETY IN 1L UNRESECTABLE HCC 

What this means for patients with HCC

  • View video transcript

    Mr. Yan:

    None of my family or friends would believe it, it was a fast-growing HCC.  The day before I experienced the pain, I went skiing with friends in Chongli Ski Resort, we also had dinner and drinks together. 

    Two days later when I came back to Beijing, I was diagnosed. The news was completely unexpected.

     

    Dr. Toh Han Chong:

    HCC is usually diagnosed late because early cancers don't have any symptoms. If untreated, it's actually a very rapidly progressive disease.  

     

    Mr. Yan:

    In less than a week, it grew from 9cm to 16cm and finally when it was removed,it was nearly 17cm.

    I was told to go home and make the most of my last three months [of] life. “Visit the places on your bucket list, enjoy the foods you love as much as possible, do whatever you want.”  I couldn’t accept it at the time, and my wife couldn’t accept it, my son was only 2 years old. 

     

    Dr. Toh Han Chong:

    In terms of the management of HCC, just to use a personal experience, when I was a young doctor the management of advanced HCC was very dismal, the median survival was just a couple of months.

    Today the world has changed phenomenally. Not only are there many drugs, there are drugs that can actually control this disease for a long period of time. 

     

    Mr. Yan:

    My greatest hope is to continue being with my family, with my wife and my son. 

    You know that’s my greatest hope.

    View video transcript

  • View video transcript

    I started taking physicals every year, probably about 30 years ago. And then in the early 90s, I was evaluated one year during my physical that I had hepatitis C. But I didn’t really get rid of it until probably the last five years. In 2010, I was diagnosed with prostate cancer. It took a few years for it to end up in remission.

     

    And only after they tried to treat the cirrhosis of the liver, afterwards I found out I had liver cancer. And only after my diagnosis of liver cancer, was I educated and told that hepatitis C was a risk factor for liver cancer. It knocked me for a loop, because I didn’t realise that my health situation is moving downhill in a sense. I go from prostate cancer to cirrhosis of the liver and then I'm hearing about liver cancer.

     

    I was sad. I was disappointed. It's like, why do I have to deal with this? But my attitude was, I'm going to hang in there. I'm willing to put forth the effort. I didn't know what it was going to take, but I was willing. And I'm glad I went along with it.

     

    I met my wife in late 2016. I think it was right around September. We were at a gathering and we didn’t know each other, but at some point during the gathering I went up and introduced myself. It was dry up until before I met her, because of the medical issues that was going on with me.

     

    My mother passed and she was probably my biggest fan. But in 2016, my best buddy passed away. So that left a void. Just at the moment that I wanted to talk, she was there. And then we got married in September 2018. I was able to look at my medical situation with two set of eyes.

     

    So you got two people asking questions instead of one. And that was real helpful to me. And then you have to do your part by being involved in the treatment. Because as long as I'm feeling like we're doing something versus doing nothing, why not do it?

     

    I may not be out of the woods, but I can see the light at the end of the tunnel. You always look forward, seeing the sun come up, and taking your next breath. That's part of the deal, whether you acknowledge it or not. I might be here a little while longer. How about that? Yes, I like that one. I guess most people would. 

    View video transcript

TECENTRIQ + bevacizumab:

REDEFINING TREATMENT
EXPECTATIONS FOR 1L
UNRESECTABLE HCC PATIENTS

A young female healthcare practitioner smiles kindly at a male patient.

INTERNATIONAL VIRTUAL LAUNCH EVENTS OF TECENTRIQ + bevacizumab

 

Watch the videos of international experts, from across the globe, diving into the groundbreaking data from IMbrave150 phase III trial, with a multidisciplinary approach.

Learn how TECENTRIQ + bevacizumab is being incorporated in clinical practice around the world:

Treating with confidence: managing patients on TECENTRIQ + bevacizumab

  • Listen to Dr. David J. Pinato, Imperial College London, UK

    • Treating with confidence: managing patients on TECENTRIQ + bevacizumab

     

    • How to use TECENTRIQ + bevacizumab in daily clinical practice and what to consider in order to use the combination in clinic and to optimise the patient experience

     

    • HCC patients may present reduced overall mental condition after diagnosis

     

    • Different AEs can have varying degrees of impact on a patient’s physical and emotional wellbeing, especially for skin disorders and fatigue which can significantly affect a patient’s quality of life

     

    • Higher QoL usually comes with longer DoT; such patients will benefit more from the regimen, therefore, it serves the ultimate goal of longer OS

     

    • In the IMbrave150 trial, TECENTRIQ + bevacizumab delayed the time to deterioration of PROs compared with sorafenib

     

    • TECENTRIQ + bevacizumab delayed deterioration of symptoms including appetite loss, diarrhoea, fatigue, jaundice and pain, which usually have a significant impact on patients’ daily lives

     

    • Most Grade 3/4 AEs in the TECENTRIQ + bevacizumab arm were usually associated with mild symptoms or are asymptomatic, hypertension, proteinuria or aminotransferase increase

     

    • Sorafenib was more associated with symptomatic AEs: PPES/HFSR and diarrhoea with a significant impact on a patient’s quality of life

     

    • The inclusion criteria from the IMbrave150 trial population is a solid foundation when selecting a patient to receive TECENTRIQ + bevacizumab

     

    • HCC patients usually have cirrhosis, a risk factor for the development of oesophageal varices, and may lead to rupture and bleeding

     

    • Not every patient needs an endoscopy for varices. If CT indicates splenomegaly or portal hypertension, such high-risk patients will be given an endoscopy. Close monitoring and prediction help to detect early, and intervene

     

    • In the IMbrave150 trial, 26% of patients in each arm had varices at baseline; only 11% of patients treated with TECENTRIQ + bevacizumab had treated varices at baseline

     

    • During treatment with the combination, routine practice should be followed such as liver function monitoring, ultrasound, endoscopy, etc

     

    • From the safety data of IMbrave150, most bleeding events with TECENTRIQ + bevacizumab were Grade 1 or 2 and manageable. The majority of bleeding events were low-grade. Rates of GI bleeding were low

     

    • There was no difference in Grade 3/4 bleeding events with the combination versus sorafenib (both 6% in each arm) and the overall rate of bleeding events with TECENTRIQ + bevacizumab was also similar to that in the REFLECT trial [Kudo et al. Lancet 2018]

     

    • TECENTRIQ + bevacizumab offers a same-day dosing schedule with consistent 3-weekly infusions. The bevacizumab dose for HCC is 15mg/kg every 3 weeks, which is similar to many other indications. This is based on dose-escalation studies that showed tolerable safety

    View video summary/key points

  • Listen to Dr. David J. Pinato, Imperial College London, UK                                 

Patient Case 2: 80 years old HBV+, hypertensive, fatty liver

  • Listen to Dr. Han Chong Toh, National Cancer Centre, Singapore

    • 80 years old, male, HBV+, treated with antivirals, Hypertensive, treated with single anti-hypertensive agent, Fatty liver. Diagnosed with rim-enhancing lesion  and multiple bilateral pulmonary metastases

     

    • Initiation of TECENTRIQ + bevacizumab. Scan showed stable hypervascular liver nodule. Multiple lung metastases smaller and one stable lung nodule has increased solid component

     

    • Patient presents Grade 3 hypertension  and Mild fatigue. If hypertension is not medically controlled, bevacizumab should be withheld and resumed once hypertension is controlled

     

    • After 34 cycles TECENTRIQ + bevacizumab was tolerated well. Patient developed Grade 3 proteinuria and had to omit his latest bevacizumab but continued with TECENTRIQ

    View video summary/key points

  • Listen to Dr. Han Chong Toh, National Cancer Centre, Singapore

Patient Case 4: 70 years old, HCV-related cirrhosis, paroxysmal atrial fibrillation and hypercholesterolemia

  • Dr. Michael Morse, Duke Cancer Institute, USA

    • Male patient with 70 years old with a HCV-related cirrhosis (Gt 4 SVR 2010) and a history of paroxysmal atrial fibrillation and hypercholesterolemia. He was diagnosed with HCC with a 2cm nodule in segment IV

     

    • From 2010 to 2014 received 4 cycles of RFA. In 2015 he was treated with TACE after recurrence in the left lobe and achieved a complete response. Between 2016 and 2018, the patient received two further ablations. In December 2019, he was found to have diffuse signal abnormality in segments II, IV and VI with indistinct margins (indistinct left lobe infiltrative lesion) ; his AFP level was 1,754 ng/mL.

     

    • No oesophageal varices, ascites or encephalopathy and had Child-Pugh class A liver function after evaluation . Initiation of treatment with TECENTRIQ + bevacizumab

     

    • Three cycles of treatment with no headaches, palpitations or heat intolerance. Reasonable appetite and  liver function tests were stable. reported Grade 2 fatigue, and diffuse myalgias in his proximal joints

     

    • After Cycle 4, imaging showed that achieved a partial response

     

    • Fatigue subsided and the patient is currently continuing to receive TECENTRIQ + bevacizumab

    View video summary/key points

  • Listen to Dr. Michael Morse, Duke Cancer Institute, USA

Patient Case 1: 65 years old, chronic HBV with no liver cirrhosis

  • Listen to Dr. Peter R. Galle, University Medical Center Mainz, Germany

    • 65 years old,  male, Chronic HBV with no liver cirrhosis. Diagnosis of HCC with pulmonary and lymph node metastases

     

    • Evaluation and inclusion in the IMbrave150 trial

     

    • Initiated TECENTRIQ + bevacizumab, presents Grade 2 rash but reaches partial response

     

    • Suffers a stroke: Left hemiplegia, Dysarthria, Intracranial haemorrhage

     

    • In follow-up brain scan, confirmation of two new brain metastases. Following the cerebral complications, discontinue bevacizumab and continue with TECENTRIQ

    View video summary/key points

  • Listen to Dr. Peter R. Galle, University Medical Center Mainz, Germany

Patient Case 3: 60 years old, history of HCV and liver cirrhosis

  • Listen to Dr. Vincent Tam, University of Calgary, Canada

    • 60 years old, female, History of HCV and liver cirrhosis. Presented severe abdominal pain to the Emergency Department and an MRI abdomen diagnosed HCC

     

    • Hepatologist discussed the case at hepatobiliary MDT rounds and the interventional radiologists (IRs) suggested TACE which was completed and resulted in a complete response

     

    • 3 months later there was recurrent growing tumour in segment VII and V; AFP. A second TACE was suggested and completed. Repeat MRI showed partial response but nodular enhancing tissue was still present

     

    • The case was discussed again at HPB MDT rounds and systemic therapy with TECENTRIQ + bevacizumab was recommended

     

    • An ultrasound-guided biopsy was performed and confirmed HCC. Hepatologist was asked to perform an EGD and band the esophageal varices

     

    • She received TECENTRIQ + bevacizumab and after 3 months (4 cycles) had a decrease in size and enhancement of the nodular enhancing HCC tissue with stability of the new (AFP decreased to 155ng/mL)

     

    • The patient tolerated TECENTRIQ + bevacizumab well. She developed cold intolerance and was found to be hypothyroid (Grade 2) after 4 cycles where her TSH was 72 mIU/L

     

    • She also developed hypertension with a blood pressure up to 174/102 (Grade 3) and was started on amlodipine 10mg daily with good effect.

     

    • She continues on TECENTRIQ + bevacizumab and has completed 10 cycles

     

    • Last MRI showed the segment IVB HCC had increased to 1.8cm, with stability of the other HCC lesions (AFP increased to 710ng/mL)

     

    • Her case will be discussed at HPB MDT rounds again for locoregional treatment options given oligoprogression

    View video summary/key points

  • Listen to Dr. Vincent Tam, University of Calgary, Canada

Resources

Curious to see more resources and download material?

Connecting YOU WITH YOUR PATIENTS
doctor_patient.jpg

CONNECTING YOU WITH YOUR PATIENTS

At Roche, we believe in a shared purpose in improving the care and treatment of patients living with difficult to treat cancers. We understand and empathise with the demands you face managing the needs of these patients.

Roche is committed to exploring new treatment options to individualise treatment and meet patients’ needs. TECENTRIQ has proven efficacy as monotherapy as well as in combination with other medicines and we are committed to exploring new combinations to improve patient outcomes (ref. SmPC). 

TECENTRIQ is an anti PD-L1 cancer immunotherapy that specifically targets PD-L1 on tumour and tumour-infiltrating immune cells across a broad range of solid tumours. TECENTRIQ offers a pioneering, targeted treatment with proven efficacy and an acceptable tolerability profile (ref. SmPC). Please see the specific indications for more information.

Connecting TECENTRIQ and COMBINATIONS
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CONNECTING TECENTRIQ AND COMBINATIONS

TECENTRIQ has proven efficacy as monotherapy as well as in combination with other medicines and we are committed to explore new combinations for better patient outcomes (ref. SmPC).

In many difficult-to-treat tumour types with a high unmet need, including metastatic urothelial carcinoma, triple negative breast cancer and lung cancer (non-small cell lung cancer and small cell lung cancer), TECENTRIQ has shown significant improvements in progression-free and/or overall survival (ref. SmPC). Importantly, treatment can be tailored (i.e., in combination with the standard of care, or different dosing schedules) according to the type of cancer and the patient’s individual needs (ref. SmPC).
Read SmPC for more details

The multiple indications of TECENTRIQ (ref. SmPC)
provide a wealth of data to inform treatment decision-making and deliver valuable reassurance when considering the needs of your patients with cancer. Please see the specific indications for more information.

Connecting PATIENTS TO THEIR LOVED ONES
patients_sisters.jpg

CONNECTING PATIENTS TO THEIR LOVED ONES

TECENTRIQ treatment offers the potential to improve treatment outcomes and maintain patient quality of life in your difficult to treat cancer patients, so they can hopefully spend more time with their loved ones.

TECENTRIQ is approved in metastatic urothelial carcinoma, non-small cell lung cancer, extensive-stage small cell lung cancer and triple negative breast cancer (ref. SmPC).

  • References & Notes

    Abbreviations

    HCC, hepatocellular carcinoma

  • References & Notes

    References & Notes

    1. TECENTRIQ SmPC available from: https://www.ema.europa.eu/en/medicines/human/EPAR/tecentriq#product-information-section (February 2021)

    2 . Li D, et al. Cancers. 2019;11:841.

    3. Kudo M, Finn R, Qin S, et al. Lancet. 2018;391:1163–1173.

    4. Finn R, et al. N Engl J Med 2020; 382:1894-1905

    5. Llovet JM et al. Hepatocellular carcinoma. Nat Rev Dis Primers. 2016;2:16018.

    6. World Health Organisation: Globocan 2020 – Liver cancer factsheet. [Internet; cited 2020 September] Available from:  http://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf 

    7. Giannini EG et al. Prognosis of Untreated Hepatocellular Carcinoma. Hepatology. 2015;61 (1):184-190.

    8. RS Finn et al. J Clin Oncol 39, 2021 (suppl 3; abstr 267).