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 need^6,7

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

TECENTRIQ has been investigated in Phase 3 studies
across NSCLC.^†

Adjuvant NSCLC

IMpower010
Read more

First-line metastatic NSCLC

IMpower150
Read more

IMpower130
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IMpower110
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Second-line metastatic NSCLC

OAK
Read more

TAIL
Read more

^†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* NSCLC^6,7

IMpower010 was a Phase 3 study (n=1280) evaluating adjuvant TECENTRIQ in patients with completely resected stage IB-IIIA NSCLC according to TNM 7^th 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

A study design infographic for the IMpower010 clinical trial describing patient population, treatments, and study endpoints.

CI, confidence interval; HR, hazard ratio:

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

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

A forest plot showing disease-free survival subgroup analysis of TECENTRIQ vs best supportive care.

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

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

The study design of IMpower150, a Phase 3 efficacy trial in first-line non-squamous NSCLC.

Carbo/pac; carboplatin/paclitaxel.

Carbo/pac, carboplatin/paclitaxel.

Carbo/pac, carboplatin/paclitaxel.

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

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.

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

The study design of IMpower130, a Phase 3 efficacy trial in first-line metastatic non-squamous NSCLC.

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

The study design of IMpower110, a Phase 3 efficacy trial in first-line non-squamous or squamous stage IV EGFR/ALK negative NSCLC.

NS, non-squamous; S, squamous.

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

The study design of OAK, a Phase 3 trial in second-line non-squamous or squamous advanced/metastatic NSCLC.

Infographic to present 1 year OS data from the OAK trial.

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

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

RESOURCES

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OTHER INDICATIONS

Learn more about TECENTRIQ and NSCLC

Learn more about TECENTRIQ and Lung Cancer

Connecting

YOU WITH YOUR PATIENTS
Connecting

TECENTRIQ and COMBINATIONS
Connecting

PATIENTS TO THEIR LOVED ONES

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

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

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).

Gridelli C, Rossi A, Carbone DP, et al. Non-small-cell lung cancer. Nat Rev Dis Primers. 2015;1:15009.
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.
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.
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.
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.
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.
TECENTRIQ (atezolizumab), Summary of Product Characteristics. June 2022. Available from: https://www.ema.europa.eu/ (Accessed June 2022).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

For Healthcare Professionals

TECENTRIQ

Connect with TECENTRIQ in non-small-cell lung cancer

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

TECENTRIQ has been investigated in Phase 3 studies across NSCLC.†

Adjuvant NSCLC

First-line metastatic NSCLC

Second-line metastatic NSCLC

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

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

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

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

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

Trend for improved OS with adjuvant TECENTRIQ at interim analysis11

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

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

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

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

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

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

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

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

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

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

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

>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

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

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

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

RESOURCES

OTHER INDICATIONS

YOU WITH YOUR PATIENTS

TECENTRIQ and COMBINATIONS

PATIENTS TO THEIR LOVED ONES

CONNECTING YOU WITH YOUR PATIENTS

References & Notes

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 need^6,7

TECENTRIQ has been investigated in Phase 3 studies
across NSCLC.^†

IMpower010: The FIRST positive trial and ONLY approved adjuvant immunotherapy in PD-L1-high resected stage II-III* NSCLC^6,7

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

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

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

Trend for improved OS with adjuvant TECENTRIQ at interim analysis¹¹

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

TECENTRIQ in combination with Avastin + carboplatin/paclitaxel provides a durable survival benefit and rapid responses for chemotherapy naïve 1L metastatic non-squamous NSCLC patients^7,8

TECENTRIQ: First cancer immunotherapy combination to demonstrate clinically meaningful survival in EGFR mutant metastatic NSCLC and liver metastases^4,9

Durable responses with TECENTRIQ combination therapy^4,9,10,12

TECENTRIQ: First cancer immunotherapy combination to demonstrate clinically meaningful survival in EGFR mutant metastatic NSCLC and liver metastases^4,9

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

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

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

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

TECENTRIQ monotherapy results in clinically meaningful survival outcomes in metastatic NSCLC without EGFR/ALK mutations^{4, 14}

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

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

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

TECENTRIQ demonstrates clinically meaningful OS in patients with previously treated advanced or metastatic NSCLC regardless of PD-L1 expression^4,15

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

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