Atezolizumab

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Atezolizumab
other names
  • MPDL3280A
  • Tecentriq
Mass / length primary structure 145 KDa
Identifier
External IDs
Drug information
ATC code L01 XC32
DrugBank DB11595

Atezolizumab (trade name: Tecentriq ; manufacturer: Roche ) is a humanized monoclonal antibody of the IgG 1κ class against PD-L1 . So there is a different inhibition goal than with the previous checkpoint inhibitors such. B. Nivolumab .

properties

The drug is made in Chinese hamster ovary cells ( CHO cells ). It has been approved in the EU since September 2017 against bronchial carcinoma (NSCLC) after conventional chemotherapy and for advanced urothelial carcinoma after conventional chemotherapy or if there is a contraindication to this. The registration study is based on a comparison against docetaxel (+ 4.2 months).

Breast cancer

In the randomized IMpassion130 study , atezolimumab was tested in combination with nab- paclitaxel in women with advanced or metastatic, triple-negative breast cancer . These are tumors that neither estrogen receptors , progesterone receptors or HER2 / neu have overexpression and therefore difficult to treat and are extremely vicious. 451 patients from 246 centers around the world who had not previously received chemotherapy were included. Treatment consisted of therapy with nab-paclitaxel and atezolizumab in the experimental group and only nab-paclitaxel in the standard arm. In tumors with PD-L1 expression, atezolizumab significantly increased the median progression-free survival from 5 to 7.5 months and the overall survival from 15.5 to 25 months. In the group as a whole, regardless of PD-L1 expression, the difference was smaller. Here progression-free survival improved from 5.5 to 7.2 months and overall survival from 17.6 to 21.3 months.

The most common possible adverse effects include decreased appetite, dyspnoea , diarrhea, nausea, vomiting, rash, itching, joint pain, fatigue, weakness, and fever. Immune-mediated inflammatory reactions are a particular side effect .

Early benefit assessment according to § 35a SGB V

The IQWiG has investigated in a dossier evaluation whether the drug as a single agent for the treatment of adult patients with advanced non-small cell lung cancer has an additional benefit compared to the appropriate comparator therapy. If treatment with docetaxel, pemetrexed or nivolumab is not indicated for the patient after prior chemotherapy, an additional benefit has therefore not been proven due to a lack of suitable study data. The Federal Joint Committee (G-BA) endorsed this assessment. If, on the other hand, treatment with docetaxel, pemetrexed or nivolumab is indicated, according to the IQWiG there is an indication of a significant additional benefit for patients with a high PD-L1 status (TC 3 or IC3) and for patients with a low PD-L1 status (TC 0/1/2 and IC0 / 1/2) an indication of a non-quantifiable added benefit. Regardless of the PD-L1 status, the G-BA saw an indication of a considerable added benefit compared to docetaxel.

Even as monotherapy for adults with locally advanced or metastatic urothelial carcinoma , the drug underwent an early benefit assessment. According to IQWiG, an additional benefit has not been proven for the first-line therapy of patients for whom chemotherapy containing cisplatin is unsuitable. The G-BA agreed with the assessment. After pretreatment with platinum-based chemotherapy, however, the IQWiG saw a hint of a considerable additional benefit; Instead, the G-BA recognized a hint of a low benefit.

The Drug Commission of the German Medical Association (AkdÄ) sees an additional benefit for atezolizumab in addition to nab-paclitaxel in the indication of triple-negative breast cancer in patients who have not received prior chemotherapy compared to the ACT named by the G-BA as not proven. The selected, non-approval-compliant comparator therapy with nab-paclitaxel does not permit any derivation of an added benefit. The G-BA decides on the additional benefit.

Individual evidence

  1. ^ Pharmaceutical newspaper: A newcomer to two types of cancer .
  2. ↑ IQWIG: Atezolizumab short version benefit assessment .
  3. ↑ L. Fehrenbacher, A. Spira, M. Ballinger, M. Kowanetz, J. Vansteenkiste, J. Mazieres, K. Park, D. Smith, A. Artal-Cortes, C. Lewanski, F. Braiteh, D. Waterkamp , P. He, W. Zou, DS Chen, J. Yi, A. Sandler, A. Rittmeyer: Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomized controlled trial. In: Lancet. Volume 387, number 10030, April 2016, pp. 1837-1846, doi : 10.1016 / S0140-6736 (16) 00587-0 , PMID 26970723 .
  4. ^ P Schmid, S Adams, HS Rugo, and others: Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. New England Journal of Medicine 2018; ; Volume 379: pp. 2108-2121. doi: 10.1056 / NEJMoa1809615
  5. ↑ A17-50 Atezolizumab (non-small cell lung cancer) - benefit assessment according to Section 35a Social Code Book V , accessed on September 3, 2018.
  6. ↑ Resolution of the Federal Joint Committee of March 16, 2018 on an amendment to the Drugs Directive (AM-RL): Annex XII - Atezolizumab (non-small cell lung cancer) , accessed on September 3, 2018.
  7. ↑ A17-51 Atezolizumab (urothelial carcinoma first line) - Benefit assessment according to Section 35a SGB V , accessed on September 3, 2018.
  8. ↑ A17-52 Atezolizumab (urothelial carcinoma) - benefit assessment according to Section 35a SGB V , accessed on September 3, 2018.
  9. ↑ Resolution of the Federal Joint Committee of March 16, 2018 on an amendment to the Drugs Directive (AM-RL): Annex XII - Atezolizumab (urothelial carcinoma) , accessed on September 3, 2018.
  10. ^ Opinion of the drug commission of the German medical profession on the early benefit assessment according to § 35a SGB V , AkdÄ: Atezolizumab new area of ​​application (breast cancer) from January 23, 2020, accessed on February 11, 2020