TECENTRIQ

Connect with TECENTRIQ in non-small-cell lung cancer 

NSCLC represents approximately 85% of all new lung cancer diagnoses. In metastatic NSCLC, TECENTRIQ—alone or in combination with cytotoxic therapy—has helped improve OS and has extended survival without progression in a broad patient population.1-5

 

Now, with adjuvant TECENTRIQ, you give people with PD-L1-high (≥50%) resected stage II-III* NSCLC, excluding EGFR/ALK+ disease the possibility of living longer free of their disease. 6,7,11

TECENTRIQ is the first and only approved adjuvant immunotherapy in PD-L1-high resected stage II-III* NSCLC, advancing the standard of care in this area of high unmet need6,7

Patients with resected NSCLC remain at high risk of cancer recurrence despite adjuvant chemotherapy. For up to ~75% of patients with resected NSCLC, cancer returns within 5 years.8

ALK, anaplastic large-cell lymphoma kinase; EGFR, epidermal growth factor receptor; NSCLC, non-small-cell lung cancer; OS, overall survival; PD-L1, programmed death-ligand 1; TNM, The Tumour/Nodal Involvement/Metastatic Spread Classification of Malignant Tumours.

*Stage II-IIIA (TNM 7th edition)/select stage II-IIIB (TNM 8th edition).7,9

TECENTRIQ has been investigated in Phase 3 studies across NSCLC.

Adjuvant NSCLC

Second-line metastatic NSCLC

These Phase 3 studies are not representative of all Phase 3 TECENTRIQ studies. 

IMpower010: The FIRST positive trial and ONLY approved adjuvant immunotherapy in PD-L1-high resected stage II-III* NSCLC6,7

 

IMpower010 was a Phase 3 study (n=1280) evaluating adjuvant TECENTRIQ in patients with completely resected stage IB-IIIA NSCLC according to TNM 7th edition staging. Patients were treated with up to 4 cycles of cisplatin-based chemotherapy before randomisation (n=1005) to treatment with TECENTRIQ for 16 cycles or best supportive care (BSC).6,7

 

The primary endpoint was investigator-assessed DFS. Key secondary endpoints included OS in the ITT population and DFS in the PD-L1-high stage II-IIIA population.7

*Stage II-IIIA (TNM 7th edition)/select stage II-IIIB (TNM 8th edition).7,9

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    TECENTRIQ is approved for PD-L1-high stage II-III NSCLC after complete resection and chemotherapy7

    The staging edition agnostic "high risk of recurrence" definition refers to patients with stage II-IIIA per the 7th edition of the TNM staging system (select stage II-IIIB based on the 8th edition).7,9

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    Advancing the standard in PD-L1-high resected stage II-III* NSCLC treatment: Adjuvant TECENTRIQ delivered superior DFS10

    IMpower010 met its primary endpoint of DFS in the PD-L1 ≥1% stage II-III* population with a pronounced benefit in the PD-L1-high population excluding EGFR/ALK+ disease (unstratified HR=0.43; 95% CI: 0.26, 0.71).7,10 The median DFS was not reached in the TECENTRIQ arm and was 37.3 months in the BSC arm.10 

    CI, confidence interval; HR, hazard ratio:

    *Stage II-IIIA (TNM 7th edition)/select stage II-IIIB (TNM 8th edition).7,9

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    Consistent DFS benefits were observed across stage and histology with adjuvant TECENTRIQ10

    In a subgroup analysis across PD-L1-high stage II-III* population, excluding EGFR/ALK+ disease, TECENTRIQ demonstrated a consistent DFS advantage versus BSC across most clinically relevant subgroups.10

    *Stage II-IIIA (TNM 7th edition)/select stage II-IIIB (TNM 8th edition).7,9

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    Trend for improved OS with adjuvant TECENTRIQ at interim analysis11

    The exploratory analysis of OS with a median follow-up of 46 months shows an OS trend in favour of adjuvant TECENTRIQ in patients with stage II-III* disease whose tumours express PD-L1 ≥1%.11

    A clinically meaningful OS trend in favour of TECENTRIQ was observed in patients with PD-L1-high (≥50%) stage II-III* NSCLC, excluding EGFR/ALK+ disease (HR=0.42), after completion of 1-4 cycles of chemotherapy.11 At 3 years, 9 out of 10 people treated with adjuvant TECENTRIQ are still alive.11

    *Stage II-IIIA (TNM 7th edition)/select stage II-IIIB (TNM 8th edition).

 In patients with resectable NSCLC, the goal is cure. Give patients the possibility of living longer free of their disease with adjuvant TECENTRIQ.

IMpower150: A Phase 3 efficacy trial in first-line non-squamous NSCLC7

A global 3-arm study in patients (n=1202) with chemotherapy-naïve non squamous metastatic NSCLC. Patients were randomised to receive TECENTRIQ + carboplatin/paclitaxel, TECENTRIQ + Avastin + carboplatin/paclitaxel, or Avastin + carboplatin/paclitaxel, respectively, until disease progression or unacceptable toxicity. Primary endpoints included OS and PFS in the intention-to-treat wild-type (ITT-WT) population (ie. EGFRwt and ALKwt).8

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    TECENTRIQ in combination with Avastin + carboplatin/paclitaxel provides a durable survival benefit and rapid responses for chemotherapy naïve 1L metastatic non-squamous NSCLC patients7,8

    TECENTRIQ combination (TECENTRIQ + Avastin + carboplatin/ paclitaxel) more than tripled the PFS benefit at 18 months versus Avastin + carboplatin/paclitaxel alone (27% vs 8% (HR=0.59; 95% CI: 0.50, 0.70)) in the ITT-WT population.7,8

     

    Median OS was 19.2 months with TECENTRIQ combination vs 14.7 months with Avastin + carboplatin/paclitaxel alone (HR 0.78; 95% CI: 0.64, 0.96) in the ITT-WT population.4,7

    Carbo/pac; carboplatin/paclitaxel.

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    TECENTRIQ: First cancer immunotherapy combination to demonstrate clinically meaningful survival in EGFR mutant metastatic NSCLC and liver metastases4,9

    OS benefit was observed in key 1L NSCLC patient segments with high unmet need:4,9,10,12

     

    ● Patients with sensitising EGFR mutations, no longer responding or not eligible for TKI therapy (not reached vs 17.5 months; HR=0.31; 95% CI, 0.11, 0.83)9

    ● Patients with liver metastases (13.3 months vs 9.4 months; HR=0.52; 95% CI: 0.33, 0.82)10

    ● Patients with bulky disease as described by multiple metastatic sites (mOS 17.6 months vs 12.5 months; HR=0.72, 95% CI: 0.58, 0.90)12

    Carbo/pac, carboplatin/paclitaxel.

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    Durable responses with TECENTRIQ combination therapy4,9,10,12

    The majority of patients responded to TECENTRIQ combination (56.4% vs 40.2%) and responses were more durable than with Avastin + carboplatin/ paclitaxel.4

     

    Response rates also increased on the TECENTRIQ combination in patients with EGFR mutations (71% vs 42%), in patients with liver metastases (60.8% vs 40.2%) and in patients with bulky disease as described by multiple metastases (57% vs 40%) compared to Avastin + carboplatin/ paclitaxel.9,10,12

    Carbo/pac, carboplatin/paclitaxel.

Prof. Martin Reck provides a summary of the IMpower150 trial design and its key results.

  • View video transcript

    The IMpower150 trial was a very important trial while weighting the role of immunotherapy in untreated patients with advanced non-small cell lung cancer.

     

    And we had a particular question. And the question was whether we can add an immunotherapy to a combination of chemotherapy and anti-angiogenic treatment. And do you see an improvement of efficacy? And do you see manageable tolerability?

     

    This was a really large trial. More than 1,000 patients were recruited to the trial. And in principle, we were comparing a four-drug regimen, chemotherapy, carboplatin, paclitaxel, Avastin and the immunotherapy of atezolizumab, to the backbone, which was the chemotherapy and Avastin.

     

    The synergy between atezolizumab and the anti-angiogenic treatment with Avastin is very interesting. And we do have a couple of preclinical data suggesting that there might be an enhancement of the activity of the immunotherapy.

     

    And indeed, we had three co-primary endpoints, progression-free survival in two groups of patients and overall survival in the intent to treat populations in patients without oncogenic alterations. And in all of these three endpoints, we did see a significant improvement of efficacy, favouring the recombination of atezolizumab, chemotherapy and Avastin.

     

    Something which is very interesting is the fact that certain subgroups were included in the IMpower150.

     

    First, patients with pre-treated oncogenic alterations like EGF receptor mutations or ALK translocations were included. And this is the only trial so far because normally, we do not believe that immunotherapy does work in this group of patients with oncogenic alterations. We did observe a significant improvement in progression-free survival and overall survival also in this subgroup of patients with pre-treated oncogenic alterations for overall survival and progression-free survival for the combination of immunotherapy, Avastin and chemotherapy. And this is of clinical interest, in particular for patients where we do not have a T790M mutation after resistance, where we are really seeking for effective treatment opportunities.

     

    And the second subgroup was the group of patients with liver metastases. And these are patients with a very unfavourable prognosis. And also in this subgroup, we did observe a substantial and clinically meaningful improvement of efficacy favouring the combination of immunotherapy, anti-angiogenic treatment and chemotherapy.

     

    Overall, this is a very interesting, a very important trial and we will learn a lot of these results coming out of the IMpower150.

This video has been produced and funded by VJ Oncology. F. Hoffmann-La Roche Ltd did not participate in the filming or editing of this video. The video reflects independent opinions of the speaker. F. Hoffmann-La Roche Ltd has been given permission to publish this video here. Prof. Martin Reck has also provided explicit permission for this video to be presented here.

TECENTRIQ: First cancer immunotherapy combination to demonstrate clinically meaningful survival in EGFR mutant metastatic NSCLC and liver metastases4,9

IMpower130: A Phase 3 efficacy trial in first-line metastatic non-squamous NSCLC13

 

A Phase 3 study in patients (n=723) with chemotherapy-naïve unresectable stage IV NSCLC randomised to receive induction therapy with TECENTRIQ + carboplatin/nab-paclitaxel or carboplatin/nab-paclitaxel followed by TECENTRIQ or best supportive care/pemetrexed, respectively, until disease progression or unacceptable toxicity. Primary endpoints were PFS and OS in the intention-to-treat wild-type (ITT-WT) population (ie. EGFRwt and ALKwt).13

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    TECENTRIQ in combination with chemotherapy demonstrated a significant 4.7-month improvement in median OS versus carboplatin and nab-paclitaxel alone in first-line metastatic NSCLC12

    Median OS of 18.6 months in patients treated with TECENTRIQ + carboplatin/nab-pac versus 13.9 months in patients receiving carboplatin/nab-pac (HR=0.79; 95% CI: 0.64, 0.98) in the ITT-WT population.

TECENTRIQ in combination with chemotherapy demonstrates a significant improvement in OS and PFS as first-line therapy in metastatic non-squamous NSCLC13

IMpower110: A Phase 3 efficacy trial in first-line non-squamous or squamous stage IV EGFR/ALK negative NSCLC13

 

A Phase 3 study in patients (n=572) with chemotherapy-naïve stage IV NSCLC randomised to receive induction therapy with TECENTRIQ or carboplatin (or cisplatin + pemetrexed [non-
squamous] or cisplatin + gemcitabine [squamous]) followed by TECENTRIQ or best supportive care (non-squamous) or pemetrexed (squamous), respectively, until disease progression or loss of clinical benefit. Primary endpoints included OS.12 

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    TECENTRIQ monotherapy significantly improved median OS versus standard-of-care chemotherapy combination13

    Median OS of 20.2 months in patients treated with TECENTRIQ versus 13.1 months in patients receiving carboplatin or cisplatin + pemetrexed (non-squamous) or + gemcitabine (squamous): HR=0.595; 95% CI: 0.398, 0.890.13

    NS, non-squamous; S, squamous.

TECENTRIQ monotherapy results in clinically meaningful survival outcomes in metastatic NSCLC without EGFR/ALK mutations4, 14

OAK: A Phase 3 efficacy trial in second-line non-squamous or squamous advanced/metastatic NSCLC14

 

A Phase 3 study in patients (n=1225) with locally advanced or metastatic NSCLC who progressed during or following a platinum-based regimen. Patients were randomised to receive TECENTRIQ or docetaxel until disease progression or unacceptable toxicity. The primary endpoint was OS.4,13

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    TECENTRIQ monotherapy significantly improved median OS versus docetaxel in second-line advanced or metastatic NSCLC14

    Median OS of 13.8 months (95% CI: 11.8, 15.7) in patients treated with TECENTRIQ monotherapy versus 9.6 months (95% CI:8.6, 11.2) with docetaxel: HR=0.73; 95% CI: 0.62, 0.87

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    >50% of patients treated with TECENTRIQ were alive at 1 year14

    An improvement in median OS was observed with TECENTRIQ versus docetaxel in both non-squamous (15.6 vs 11.2 months; HR=0.73; 95% CI: 0.60, 0.89) and squamous (8.9 vs 7.7 months; HR=0.73; 95% CI: 0.54, 0.98) NSCLC14

    • Improved OS was observed with TECENTRIQ at all levels of PD-L1 expression, including for patients with little or no expression (tumour cell and tumour infiltrating IC <1%: 12.6 vs 8.9 months; HR=0.75; 95% CI: 0.59, 0.96)15
    • ORR in the intension-to-treat population was comparable between treatment groups (14% vs 13%)15

TECENTRIQ demonstrates clinically meaningful OS in patients with previously treated advanced or metastatic NSCLC regardless of PD-L1 expression4,15

TAIL: A Phase 3/4 safety trial in a diverse patient population with NSCLC15

 

Patients with Stage lllb/IV NSCLC who experience disease progression after 1–2 lines of standard chemotherapy received TECENTRIQ 1200 mg IV q3w until disease progression or unacceptable toxicity. The primary endpoint was treatment-related safety. 15

TECENTRIQ monotherapy safety profile confirmed in a diverse, previously treated NSCLC patient population16

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Connecting YOU WITH YOUR PATIENTS
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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
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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

    References & Notes

    1. Gridelli C, Rossi A, Carbone DP, et al. Non-small-cell lung cancer. Nat Rev Dis Primers. 2015;1:15009.
    2. Rittmeyer A, Barlesi F, Waterkampet D, et al; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389:255-265.
    3. Socinski MA, Jotte RM, Cappuzzo F, et al; IMpower150 Study Group. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC.
      N Engl J Med. 2018;378:2288-2301.
    4. West H, Batus M, Bernickeret E, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial.
      Lancet Oncol. 2019;20:924-937.
    5. Herbst RS, Giaccone G, de Marinis F, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. N Engl J Med. 2020;383:1328-1339.
    6. Felip E, Altorki N, Zhou C, et al; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398:1344-1357.
    7. TECENTRIQ (atezolizumab), Summary of Product Characteristics. June 2022. Available from: https://www.ema.europa.eu/ (Accessed June 2022).
    8. Pignon J-P, Tribodet H, Scagliotti GV, et al; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.
    9. Goldstraw P, Chansky K, Crowley J, et al. The IASLC Lung Cancer Staging Project: proposals for revision of the TNM stage groupings in the forthcoming (eighth) edition of the TNM Classification for lung cancer. J Thorac Oncol. 2016;11:39-51.
    10. Felip E, Altorki N, Zhou C, et al. Atezolizumab vs best supportive care in stage II-IIIA NSCLC with high PD-L1 expression: sub-analysis from the pivotal phase III IMpower010 study. Presented at: European Lung Cancer Congress; 30 March-2 April 2022.
    11. Felip E, Altorki N, Valliers E et al. IMpower010: Overall survival interim analysis of a phase III study of atezolizumab vs best supportive care in resected NSCLC. Presented at: World Conference on Lung Cancer 2022.
    12. Socinski MA, et al. Interim analysis of IMpower150 shows improved overall survival with atezolizumab combination in the ITT population and across all subgroups. Presented at: American Society of Clinical Oncology Annual Meeting; 1-5 June 2018. Abstract 9002.
    13. Reck M, Mok TSK, Nishio M, et al. Atezolizumab plus Avastin and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019;7:387-401.
    14. Socinski MA, Jotte RM, Cappuzzo F, et al. IMpower150: analysis of efficacy in patients (pts) with liver metastases (mets). Presented at: American Society of Clinical Oncology Annual Meeting; 31 May-4 June 2019. Abstract 9012.
    15. Jotte RM, Batus M, Bernicker E, et al. IMpower150: exploratory efficacy analysis in patients (pts) with bulky disease. Presented at: American Society of Clinical Oncology Annual Meeting; 29-31 May 2020. Abstract e21637.
    16. Spigel D, Marinis FG, Giaccone et al. IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC. Presented at: European Society for Medical Oncology Congress; 27 September-1 October 2019. Abstract LBA78.
    17. Ardizzoni A, Azevedo S , Rubio-Viqueira S, et al. Primary results from TAIL, a global single-arm safety study of atezolizumab (atezo) monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer (NSCLC). Ann Oncol. 2019;30(Suppl 5):v920-v921.