Atezolizumab

Refrigerated Storage · New Medicines ·
34596011000001107

Refrigerated Storage

Tecentriq · Roche Products Ltd

Roche Products Ltd
Tecentriq
Concentrate for solution for infusion, 840mg and 1200mg

Contact Roche Products Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Storage at ambient temperature: not provided by manufacturer

Do not freeze. Keep the vial in the outer carton in order to protect from light.

28th September 2020
London MI Service

New Medicines

Tecentriq · Triple-negative, metastatic breast cancer - first-line in combination with nab-pacitaxel (Abraxane)

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Launched
Launched
Launched
September 2019
Sep 19 · Available in the UK. Price 1 x 14ml vial = £2665.38 [18, 19].
Aug 19 · Approved in EU [17].
Jun 19 · Recommended for EU approval by CHMP - the additional indication is "Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.” An additional presentation containing 840 mg is intended to be licensed for this indication [16].
Mar 19 · Q1 Currently pre-registration in EU. MAA was filed Sep 18 [15].
Mar 19 · Granted EAMS status in UK for first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% [14].
Mar 19 · The US FDA granted accelerated approval for atezolizumab plus Abraxane to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in pts whose tumors expressed PD-L1. This followed data from the PIII IMpassion130 trial. Under this approval process, confirmatory clinical trials have to be continued [13].
Nov 18 · US FDA grants priority review to atezolizumab for use with Abraxane (paclitaxel) in initial treatment of metastatic triple-negative breast cancer expressing PD-L1. Decision expected Mar 12 [12].
Oct 16 · Filings will be in 2018 [5].
Jul 15 · EU & US filings planned for 2018 or later [1].

Category

Immunotherapy, interferes with a protein called PD-L1 (Programmed Death-Ligand 1).
15% of patients with breast cancer have triple negative disease.
Triple-negative, metastatic breast cancer - first-line in combination with nab-pacitaxel (Abraxane)
Intravenous

Further information

Yes
July 2020

Trial or other data

Oct 18 · Results of PIII IMpassion130 (NCT02425891) study published in NEJM. RCT (n=902) showed greater median PFS of 7.2 months with atezolizumab + nab-paclitaxel (NP) vs 5.5 with placebo-NP in both ITT (HR 0.8, P=0.002) and programmed death ligand 1-positive subgroup (7.5 months vs 5 months; HR 0.62, P<0.001) [11].
Oct 18 · Interim data from PIII IMpassion 130trial presented at the European Society for Medical Oncology annual meeting show that Tecentriq + Abraxane in newly diagnosed pts reduced risk of disease worsening or death by 20%. The combination delayed progression by a median 7.2 monthsvs. 5.5 months for solo chemo. In pts with tumors testing positive for PD-L1, the combination reduced risk by 38% and delayed progression for 7.5 months vs. 5 months for the control group. The company commented that, while the study hadn’t yet met the statistical significance mark for overall survival at the interim check-in, the numbers did show a “clinically meaningful” improvement in PD-L1-positive patients [10].
Jul 18 · Roche announce topline data from PIII IMpassion130 trial (n=902) which showed taht Tecentriq + nab-paclitaxel met co-primary endpoint of progression-free survival (PFS). The trial evaluated Tecentriq + nab-paclitaxel vs. placebo + nab-paclitaxel in pts with locally advanced / metastatic TNBC who had not received previous systemic therapy for metastatic breast cancer (mBC) [9].
Dec 17 · NCT03125902= IMpassion131 due Feb 2019, NCT02425891=IMpassion130 due Apr 2020 [8].
Jun 17 · Q2 Recruitment complete in PIII IMpassion130 study [7].
Nov 16 · PIII IMpassion130 (NCT02425891) now expects to complete collection of primary outcome data in Apr 20 [6].
Dec 15 · Companion diagnostic test also in development and will be required to identify suitable patients [4].
Dec 15 · Roche announces results from a PIb study of atezolizumab used in combination with nab-paclitaxel in patients with metastatic triple-negative breast cancer (TNBC). The study showed that the combination shrank tumours (overall response rate, including unconfirmed responses) in 70.8% of people, [n=24; 95% confidence interval, (CI): 48.9, 87.4]. 11 of 17 responses (65%) continued on treatment at time of data cut-off. The highest overall response rate observed [88.9% (CI: 51.7, 99.7)] was in people receiving their initial (1st line) treatment for metastatic disease, with 1 confirmed complete responder. Responses were observed in both PD-L1 positive and PD-L1 negative patients. In addition, some patients with evidence of RECIST based progressive disease developed further response with continued treatment. Adverse events (AEs) were consistent with what has previously been reported for treatment of nab-paclitaxel alone, with 56% of patients (n=32) experiencing Grade 3–4 AEs [3].
Sep 15 · PIII IMpassion (NCT02425891) study is recruiting pts from the US, Canada, Australia, Belgium, Republic of Korea, Germany & UK. Collection of primary outcome data should complete May 2019 [2].
Jun 15 · Q2 First pt enrolled in PIII IMpassion 130 study (n=350). Progression-free survival will be compared in pts receiving atezolizumab plus nab-paclitaxel (arm 1) and placebo plus nab-paclitaxel (arm B) [1].

Evidence based evaluations

Tecentriq · Non-squamous non-small cell lung cancer (NSCLC) - first-line in combination with chemotherapy and nab-paclitaxel

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Launched
Launched
Launched
September 2019
Dec 19 · Approved in US [11]
Sep 19 · Approved in EU [9]
Jul 19 · Recommended for EU approval by CHMP - the additional indication is "in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC (see section 5.1)." [8].
Nov 18 · Filed in US [7].
Oct 18 · Filed in EU [6].

Category

Immunotherapy, interfers with with a protein called PD-L1 (Programmed Death-Ligand 1).
Lung cancer is the second most common cancer in the UK accounting for 13% of all new cases. In England and Wales, there were 37,290 new diagnoses in 2011, and in 2013, 30,424 deaths from NSCLC were registered. Approximately 87% of lung cancers are NSCLC, and around 70-75% of these are non-squamous.
Non-squamous non-small cell lung cancer (NSCLC) - first-line in combination with chemotherapy and nab-paclitaxel
Intravenous

Further information

Yes
Suspended

Trial or other data

Jul 19 · PIII IMpower 130 published in Lancet Oncology 2019; 20(7): 924-37 [10].
May 19 · Results from the PIII IMpower 130 RCT (n=723) showed significantly improved median overall survival of 18.6 months in the atezolizumab plus chemotherapy group vs 13.9 months in chemotherapy group, p=0.033) and a significantly improved progression-free survival (7.0 months vs 5.5 months respectively, p<0.0001) [7].
Oct 18 · New data from IMpower 130 (n=723) reported at the annual European Society for Medical Oncology Congress, showed that the combination therapy of atezolizumab plus carboplatin and nab-paclitaxel enhanced survival vs chemotherapy alone (median overall survival OS=18.6 vs 13.9 months; hazard ratio [HR]=0.79; 95% CI: 0.64 – 0.98; p=0.033) and lowered the risk of disease worsening or death/progression-free survival (median PFS=7.0 vs 5.5 months; HR=0.64; 95% CI: 0.54–0.77; p<0.0001) [4,5].
May 18 · Roche announces that the PIII IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) [3].
Mar 15 · PIII IMpower130 trial designed to assess the safety and efficacy of atezolizumab in combination with carboplatin and nab-paclitaxel in chemotherapy-naive patients with late-stage non-squamous non-small cell lung cancer starts (NCT02367781). Progression free survival at 2.5 years is the defined primary endpoint of the trial. 724 patients will be recruited worldwide. Collection of primary outcome data due to complete Mar 18 [1,2].

Evidence based evaluations

Tecentriq · Small cell lung cancer - extensive-stage, first-line in combination with chemotherapy

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Launched
Launched
Launched
September 2019
Yes
Sep 19 · New indication for Tecentriq 1,200mg concentrate for solution for infusion approved in EU [16].
Jul 19 · Recommended for EU approval by CHMP - the additional indication is "in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1)." [15].
Jun 19 · Granted Early Access to Medicines Scheme (EAMS) status in UK for first line treatment of adults with extensive-stage small cell lung cancer, in combination with carboplatin and etoposide [14].
Mar 19 · Approved in US [13].
Sep 18 · Filed in EU [12].
Sep 18 · Filed in the US with priority review designation. Decision on approval expected Mar 2019 [11].
Oct 16 · Granted orphan drug status in US [4].
Jul 16 · EU & US filings planned for 2018 [1].

Category

Immunotherapy, interferes with a protein called PD-L1 (Programmed Death-Ligand 1)
Lung cancer is the third most common cancers in the UK: about 45,500 new cases were diagnosed in the UK in 2013. About 10-15% of cases are classified as SCLC [3].
Small cell lung cancer - extensive-stage, first-line in combination with chemotherapy
Intravenous

Further information

Yes
To be confirmed

Trial or other data

Sep 18 · Results of IMpower133 (NCT02763579) published in NEJM [9].
Sep 18 · Results from IMpower133 study announced, showing that atezolizumab and chemotherapy modestly increased overall survival (OS) vs chemotherapy alone (OS = 12.3 months vs 10.3 months; hazard ratio [HR] = 0.70, 95%CI: 0.54-0.91; p=0.0069) in the intention-to-treat (ITT) population. The atezolizumab-based combination also significantly reduced the risk of progression-free survival (PFS) vs chemotherapy alone (PFS=5.2 months vs 4.3 months; HR=0.77, 95%CI: 0.62-0.96; p=0.017). Safety for the atezolizumab and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified. Results will be published in the NEJM [8].
Jun 18 · Roche announce PIII IMpower 133 trial its co-primary endpoints. An interim data analysis (n=403 treatment naive) showed survival benefit (progression-free and overall survival) with this combination compared to chemotherapy alone in this difficult-to-treat population. Data will be presented at upcoming medical conference [6].
Jun 17 · Q2 Recruitment complete in PIII IMpower133 study [5].
Jun 16 · PIII IMpower 133 (NCT02763579) starts. This PIII study will evaluate safety and efficacy of atezolizumab in combination with carboplatin plus etoposide vs. placebo + carboplatin + etoposide in treatment-naive participants with extensive-stage small cell lung cancer (ES-SCLC). Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21 day-cycles for 4 cycles in the induction phase followed by maintenance with atezolizumab or placebo until disease progression (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration. 400 adults will be recruited from sites globally including the US & EU (incl UK). Collection of primary outcome data should complete Jun 19 [1,2].

Evidence based evaluations

Tecentriq · Hepatocellular carcinoma (HCC) - first-line in combination with bevacizumab

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Launched
Launched
Launched
November 2020
Nov 20 · Approved in the EU [14]
Sep 20 · The CHMP has recommended approval of atezolizumab in combination with bevacizumab for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have not received prior systemic therapy [13].
Jun 20 · Granted EAMS status in UK [12].
May 20 · Approved in US. This was based on data from the Phase III IMbrave 150 trial. [11]
Jan 20 · Filed in EU [9].
Jan 20 · A submission of an sBLA has been made to the U.S. FDA for atezolizumab combined with bevacizumab for the treatment of people with unresectable hepatocellular carcinoma [8].
Oct 19 · Filings now 2020 [6].
Jan 19 · Filings in US & EU planned for 2019 [4].

Category

Immunotherapy, interferes with a protein called PD-L1 (Programmed Death-Ligand 1).
The age-standardised incidence rate for liver cancer in the UK in 2008 was 4.3 per 100,000 population. HCC is the most common type of primary liver cancer [1].
Hepatocellular carcinoma (HCC) - first-line in combination with bevacizumab
Intravenous

Further information

Yes
December 2020

Trial or other data

May 20 · PIII IMbrave150 is published; the RCT (n=336) found atezolizumab combined with bevacizumab resulted in better overall (67.2% vs. 54.6% at 12 months; HR for death 0.58; 95% CI, 0.42-0.79; p<0.001) and progression-free (6.8 vs. 4.3 months; HR 0.59; 95% CI, 0.47 to 0.76; p<0.001) survival outcomes than sorafenib [10].
Nov 19 · PIII trial Imbrave150 found atezollizumab in combination with Avastin reduced the risk of death (OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib [7].
Oct 19 · PIII Imbrave150 study show combination beat SOC at stalling cancer progression and helped them live longer [5].
Jan 19 · Recruitment completes in PIII IMbrave150 study [4].
Jan 18 · First patient enrolled in PIII IMbrave150 study comparing atezolizumab plus bevacizumab with sorafenib in 480 patients in countries including the US & EU (plus UK) (NCT03434379). Primary outcomes are overall survival and objective response rate; collection of these data is due to complete May 21 [2,3].

Evidence based evaluations

Tecentriq · Non-squamous non-small cell lung cancer (NSCLC) - first-line monotherapy in PD-L1 selected patients

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Launched
Jun 20 · Approved in US for 1st-line treatment for metastatic NSCLC with high PD-L1 expression. An accompanying FDA-approved diagnostic test is used to determine PD-L1 status [6].
May 20 · Approved in US [5].
Nov 19 · Filed in EU & US for first-line monotherapy for advanced non-squamous and squamous (NSCLC) without EGFR or ALK mutations with high PD-L1 expression [4].
Oct 19 · Filing for monotherapy of PD-L1 selected patients (using data from IMpower110) planned for 2020 [1].

Category

Immunotherapy, interfers with with a protein called PD-L1 (Programmed Death-Ligand 1).
UK incidence of advanced NSCLC is 40 per 100,000 people. 42% of NSCLC are squamous [3].
Non-squamous non-small cell lung cancer (NSCLC) - first-line monotherapy in PD-L1 selected patients
Intravenous

Further information

Yes
June 2021

Trial or other data

Oct 20 · PIII IMpower110 RCT (n=572) found that atezolizumab resulted in longer overall survival than platinum-based chemotherapy in subgroup of patients with EGFR and ALK wild-type tumours with highest expression of PD-L1 (20.2 vs. 13.1 months; HR death, 0.59; p=0.01) [7].
Oct 19 · Roche announce PIII IMpower 110 (NCT02409342) study (n=555) met primary endpoint in interim analysis, demonstrating statistically significant OS benefit in people with high PD-L1 expression (TC3/IC3-WT) vs. chemotherapy alone [2].
Sep 15 · PIII IMpower 110 study begins recruitment of 570 PD-L1-selected pts with non-squamous NSCLC (and squamous) and compares atezolizumab monotherapy with carboplatin/cisplatin + pemetrexed [1].

Evidence based evaluations

Tecentriq · Squamous non-small cell lung cancer (NSCLC) - first-line monotherapy in PD-L1 selected patients

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Launched
May 20 · Approved in US for 1st-line treatment for metastatic NSCLC with high PD-L1 expression. An accompanying FDA-approved diagnostic test is used to determine PD-L1 status.[18]
Feb 20 · FDA accepts sBLA for atezolizumab as first-line monotherapy for advanced non-squamous and squamous (NSCLC) without EGFR or ALK mutations with high PD-L1 expression, for priority review [16].
Nov 19 · Filed in EU for first-line monotherapy for advanced non-squamous and squamous (NSCLC) without EGFR or ALK mutations with high PD-L1 expression [17].
Oct 19 · PIII development of atezolizumab in combination with nab-paclitaxel for first-line treatment of squamous NSCLC discontinued and no plans for filing. Filing for monotherapy of PD-L1 selected patients (using data from IMpower110) planned for 2020 [15].
Jan 19 · EU & US filings planned for 2019 [10].
Oct 18 · Filings yet to have been made [9].
Jul 16 · Filings now planned for 2018 [5].
Apr 15 · EU & US filings predicted 2018 or later [1].

Category

Immunotherapy, interfers with with a protein called PD-L1 (Programmed Death-Ligand 1).
UK incidence of advanced NSCLC is 40 per 100,000 people. 42% of NSCLC are squamous [3].
Squamous non-small cell lung cancer (NSCLC) - first-line monotherapy in PD-L1 selected patients
Intravenous

Further information

Yes
February 2021

Trial or other data

Oct 20 · PIII IMpower110 RCT (n=572) found that atezolizumab resulted in longer overall survival than platinum-based chemotherapy in subgroup of patients with EGFR and ALK wild-type tumours with highest expression of PD-L1 (20.2 vs. 13.1 months; HR death, 0.59; p=0.01) [19].
Sep 20 · Updated results of PIII IMpower131 study reported at the World Conference of Lung Cancer. Median OS was 14.2 months in arm B (atezolizumab plus chemotherapy; n=343) vs 13.5 months in arm C (chemotherapy alone; n=340), not crossing the boundary for statistical significance (HR=0.88; 95% CI, 0.73-1.05; p=0.16). In the PD-L1–high tumour expression subgroup, median OS was 23.4 vs 10.2 months, respectively (HR=0.48; 95% CI, 0.29-0.81). No new safety signals were observed in this study, but the incidence of grade 3/4 treatment-related adverse events was higher for patients who received atezolizumab vs those who did not (68% vs 57.5%) [12-14].
Sep 19 · Roche announce PIII IMpower 110 (NCT02409342) study (n=555) met primary endpoint in interim analysis, demonstrating statistically significant OS benefit in people with high PD-L1 expression (TC3/IC3-WT) vs. chemotherapy alone [11].
Jan 19 · Interim OS data has been presented at ESMO 2018 [10].
Jun 18 · Roche announce further data from PIII IMpower131 study (n=1,021). At 12 months, median PFS in patients on atezolizumab monotherapy was 6.3 months vs 5.6 months in the chemotherapy group [8].
Mar 18 · Phase III clinical trial, IMpower131, of Tecentriq (atezolizumab) with carboplatin and Abraxane met its co-primary endpoint of PFS in squamous NSCLC. Although a statistically significant OS benefit wasn’t seen, the study will continue.[7]
Mar 17 · Recruitment complete in the PIII IMpower131 study involving 1,025 patients with squamous NSCLC. Patients have been randomised to first-line treatment in one of the 3 arms: Arm A atezolizumab plus paclitaxel + carboplatin; Arm B atezolizumab plus nab-paclitaxel + carboplatin; Arm C nab-paclitaxel + carboplatin. PFS & OS will be assessed [6].
Jul 16 · PIII IMpower 110 (NCT02409342) study (n=400) is currently recruiting PDL1-selected pts with squamous or non-squamous NSCLC from sites globally (including the UK). Primary outcome data collection is expected to complete Apr 2018. PIII IMpower 111 is to be consolidated into IMpower 110. IMpower 111 began in Q2 15 and is recruiting 400 PDL1-selected patients with squamous NSCLC and comparing atezolizumab monotherapy with gemcitabine plus cisplatin or carboplatin [3].
Dec 15 · companion diagnostic test also in development and will be required to identify suitable patients [4].
Jun 15 · PIII IMpower 111 (NCT02409355) study (n=400) is designed to evaluate and compare safety and efficacy of atezolizumab (MPDL3280A) compared with treatment with gemcitabine + cisplatin or carboplatin in patients with chemotherapy-naive, Stage IV squamous NSCLC. Study sites include the US & EU (inc. UK). Collection of PFS primary outcome data should complete Jul 19 [2].
Jun 15 · Roche announce patient enrolment begins in two PIII studies. In one, 1,200 pts will be recruited to assess the effects of RG7446 with nab-paclitaxel or paclitaxel and carboplatin vs. chemotherapy alone on progression-free survival. The second study will recruit 400 PD-L1-selected pts and compare RG7446 monotherapy vs. chemotherapy (gemcitabine + carboplatin/cisplatin) [1].

Evidence based evaluations

Tecentriq · Malignant melanoma, BRAFv600 mutation-positive metastatic or unresectable locally advanced - first-line in combination with cobimetinib and vemurafenib

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
May 20 · Filed in US [11].
Apr 20 · EU & US filings planned for 2019 [4].
Oct 19 · Filings will now be 2020 [6].
Oct 18 · Filings still on course for 2019 [5].
Mar 17 · PIII study has started [3].

Category

Immunotherapy, interferes with a protein called PD-L1 (Programmed Death-Ligand 1)
The UK incidence of malignant melanoma is about 21 per 100,000 people, and is doubling every 10-20 years. BRAF cancer-causing mutation occurs in about 50% of melanomas. Brain metastases are common in pts with cutaneous melanoma & associated with a poor prognosis. Surgery & radiotherapy may provide local control in pts with few metastases.
Malignant melanoma, BRAFv600 mutation-positive metastatic or unresectable locally advanced - first-line in combination with cobimetinib and vemurafenib
Intravenous

Further information

Yes
To be confirmed

Trial or other data

Jun 20 · In the PIII IMspire150 study (n=514), the addition of atezolizumab to vemurafenib and cobimetinib was associated with prolonged progression-free survival (15.1 vs 10.6 months with vemurafenib plus cobimetinib [control]; HR 0.78; 95% CI 0.63-0.97; p=0.025) [10].
Apr 20 · Results of the PIII IMspire 150 TRILOGY study were presented virtually at the American Association for Cancer Research annual meeting. Adding atezolizumab to cobimetinib and vemurafenib decreased the risk of disease progression or death by 22% vs cobimetinib and vemurafenib alone. Patients on the triple combination went a median 15.1 months without their disease worsening, vs 10.6 months for those who didn’t receive atezolizumab as part of their treatment. Overall patients responded at a similar rate to both combinations, but responses lasted longer for those taking the triple combination, coming in at a median 21 months vs 12.6 months [9].
Dec 19 · Primary endpoint of improved PFS is met in PIII IMspire150 study [8].
Nov 19 · PIII IMspire 150 TRILOGY study (NCT02908672) finished collecting primary outcome data in Oct 19 [7].
Oct 18 · PIII IMspire 150 TRILOGY study (NCT02908672) enrolled the last patient in Q2 18 [5].
Nov 16 · Roche plans to initiate a randomised PIII trial to assess the safety, efficacy and pharmacokinetics of combination of atezolizumab, cobimetinib and vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma (CO39262; NCT02908672). The double-blind trial anticipates enrolment of approximately 500 patients in Austria, Belgium, Israel, Netherlands and Switzerland. the study is due to start in Feb 17, and collection of primary outcome data (PFS) should complete Feb 2020 [2].
Nov 16 · Roche reports data from two PIb studies. In one study in 30 previously untreated patients with BRAF-positive melanoma, atezolizumab in combination with Cotellic and Zelboraf delivered an 83% response rate--or 24 patients--with a complete response in three of them. The regimen was well-tolerated; 40% of patients had side effects that resolved with appropriate interventions. In the other study in 22 melanoma patients who hadn’t previously been treated with a PD-1/PD-L1 drug, Tecentriq plus Cotellic performed in those with and without the BRAF mutation. The response rate was lower here--45% overall--but the study was long enough to generate some survival data. The combination held off cancer progression for 12 months, 15.7 months in the BRAF-positive patients and 11.9 months in the non-BRAF group [1].

Evidence based evaluations

Tecentriq · Locally advanced or metastatic urothelial cancer in adults - first-line monotherapy or with chemotherapy

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Immunotherapy, interfers with with a protein called PD-L1 (Programmed Death-Ligand 1).
UK incidence of bladder cancer is 11.4 per 100,000 population. The vast majority of bladder cancers in the UK are transitional cell carcinomas (also known as urothelial cell carcinomas). The recurrence rate for superficial transitional cell cancer of the bladder is high (70% within five years). As many as 80% of pts have at least one recurrence.
Locally advanced or metastatic urothelial cancer in adults - first-line monotherapy or with chemotherapy
Intravenous

Further information

Yes
July 2021

Evidence based evaluations

Tecentriq · Non-small cell lung cancer (NSCLC) - adjuvant therapy

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Immunotherapy, interferes with a protein called PD-L1 (Progarmmed Death-Ligand 1).
UK incidence of advanced NSCLC is 40 per 100,000.
Non-small cell lung cancer (NSCLC) - adjuvant therapy
Intravenous

Further information

Yes
To be confirmed

Evidence based evaluations

Tecentriq · Renal cell carcinoma - adjuvant therapy

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Immunotherapy, interfers with with a protein called PD-L1 (Programmed Death-Ligand 1).
Renal cancers account for approximately 2-3% of all malignancies. In 2009, there were 9,286 new cases of kidney cancer in the UK: 5,706 (61%) in men and 3,580 (39%) in women, giving a male:female ratio of 16:10.
Renal cell carcinoma - adjuvant therapy
Intravenous

Tecentriq · Urothelial (bladder) cancer, high-risk, muscle-invasive, PD-L1-positive patients - adjuvant therapy

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Feb 20 · Development discontinued [12].

Category

Immunotherapy, interferes with a protein called PD-L1 (Programmed Death-Ligan 1).
In 2012 there were 9,124 cases of bladder cancer diagnosed in England. In the same year there were 4,379 deaths due to bladder cancer registered in England.
Urothelial (bladder) cancer, high-risk, muscle-invasive, PD-L1-positive patients - adjuvant therapy
Intravenous

Further information

Yes
To be confirmed

Trial or other data

Jan 20 · PIII IMvigor010 trial (n=809) fails to meet primary endpoint of disease-free survival (DFS) when compared with no treatment [11].

Evidence based evaluations

Tecentriq · Metastatic castration-resistant prostate cancer - in combination with enzalutamide

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jul 19 · Development stopped [6].

Category

Immunotherapy, interfers with with a protein called PD-L1 (Programmed Death-Ligand 1).
The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population [1].
Metastatic castration-resistant prostate cancer - in combination with enzalutamide
Intravenous

Trial or other data

Jun 19 · PIII IMbassador250 (NCT03016312) study stopped due to futility [6].

Tecentriq · Advanced untreated renal cell carcinoma - monotherapy or in combination with bevacizumab

Information

Tecentriq
Licence extension / variation
Roche
Roche

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 20 · Removed from Roche planned filings and development discontinued [13].

Category

Immunotherapy, interfers with with a protein called PD-L1 (Programmed Death-Ligand 1).
Renal cancers account for approximately 2-3% of all malignancies. In 2009, there were 9,286 new cases of kidney cancer in the UK: 5,706 (61%) in men and 3,580 (39%) in women, giving a male:female ratio of 16:10.
Advanced untreated renal cell carcinoma - monotherapy or in combination with bevacizumab
Intravenous

Further information

Yes
Suspended

Evidence based evaluations