Jemperli arrives just as accelerated approvals face a grilling

With yesterday’s green light for Glaxosmithkline’s dostarlimab, some five months late owing to Covid-19 travel restrictions, the industry has its seventh US-approved anti-PD-(L)1 drug. The initial use, second-line mismatch repair-deficient endometrial cancer, is a small niche, and Merck & Co’s Keytruda can already be given for second-line MSI-high/mismatch repair-deficient cancers – irrespective of tumour type. Immediate winners are Roche, whose Ventana MMR RxDx companion diagnostic is concurrently approved, and Anaptysbio, which scored a $20m milestone payment; Glaxo investors might now wonder how long it will be before dostarlimab, now branded Jemperli, generates the cash flow to cover the milestone. Evaluate Pharma sellside consensus sees Jemperli revenues rising from an anaemic $37m this year to $546m in 2026. The conditional approval came five days before a US adcom seeking to scrutinise the ongoing accelerated approvals of anti-PD-(L)1 drugs whose confirmatory studies have failed. As a just-published report from Evaluate Vantage reveals, this conditional pathway has found particular favour with anti-PD-(L)1 drugs, with Keytruda alone having 18 accelerated approvals to its name, 11 of which remain unconfirmed. Jemperli plus chemo is in Ruby, a controlled phase 3 endometrial cancer study that might be used to confirm yesterday’s approval.

US accelerated approvals of anti-PD-1/PD-L1 MAbs
Approval date Therapy Indication Current approval status
Jemperli (Glaxosmithkline/Anaptysbio)
22 Apr 2021 Monotherapy 2nd-line mismatch repair-deficient endometrial cancer Not converted
Libtayo (Sanofi-Regeneron)
9 Feb 2021 Monotherapy 2nd-line or Hedgehog inhibitor-inappropriate basal cell carcinoma Not converted
Imfinzi (Astrazeneca)
1 May 2017 Monotherapy 2nd-line urothelial carcinoma Withdrawn
Bavencio (Pfizer/Merck KGaA)
9 May 2017 Monotherapy 2nd-line urothelial carcinoma Converted to full approval
23 Mar 2017 Monotherapy 2nd-line Merkel cell carcinoma Not converted
Tecentriq (Roche)
8 Mar 2019 Abraxane combo 1st-line PD-L1 +ve  (≥1%) triple-negative breast cancer Not converted
17 Apr 2017 Monotherapy 1st-line urothelial carcinoma (chemo ineligible; PD-L1 ≥5% if eligible for non-cisplatin) Not converted; additional restriction
18 May 2016 Monotherapy 2nd-line urothelial carcinoma Withdrawn
Opdivo (Bristol-Myers Squibb/Ono)
16 Apr 2021 Chemo combo 1st-line gastric/GEJ/oesophageal adenocarcinoma Not converted
10 Mar 2020 Yervoy combo 2nd-line liver cancer Not converted
17 Aug 2018 Monotherapy 3rd-line SCLC Withdrawn
10 Jul 2018 Yervoy combo 2nd-line MSI-H or mismatch repair-deficient colorectal cancer  Not converted
22 Sep 2017 Monotherapy 2nd-line liver cancer Not converted
31 Jul 2017 Monotherapy 2nd-line MSI-H or mismatch repair-deficient colorectal cancer  Not converted
2 Feb 2017 Monotherapy 2nd-line urothelial carcinoma Not converted
17 May 2016 Monotherapy 3rd-line classical Hodgkin lymphoma  Not converted
23 Jan 2016 Yervoy combo 1st-line Braf-positive melanoma  Converted to full approval
23 Jan 2016 Monotherapy 1st-line Braf-positive melanoma  Converted to full approval
30 Sep 2015 Yervoy combo 1st-line Braf-W/T melanoma Converted to full approval
22 Dec 2014 Monotherapy 2nd-line melanoma Converted to full approval
Keytruda (Merck & Co)
13 Nov 2020 Chemo combo 1st-line PD-L1 +ve  (≥10%) triple-negative breast cancer Not converted
24 Jun 2020 Monotherapy Cutaneous squamous cell carcinoma not eligible for surgery/RT Not converted
16 Jun 2020 Monotherapy 2nd-line TMB-high (≥10mut/Mb) solid tumours Not converted
28 Apr 2020 Monotherapy 400mg q 6wk in all adult indications Not converted
17 Sep 2019 Lenvima combo 2nd-line, not MSI-H/dMMR, endometrial carcinoma  Not converted
17 Jun 2019 Monotherapy 3rd-line SCLC Withdrawn
19 Dec 2018 Monotherapy 1st-line Merkel cell carcinoma Not converted
9 Nov 2018 Monotherapy 2nd-line liver cancer Not converted
13 Jun 2018 Monotherapy 3rd-line primary mediastinal large B-cell lymphoma  Converted to full approval
12 Jun 2018 Monotherapy 2nd-line PD-L1 +ve (≥1%) cervical cancer Not converted
22 Sep 2017 Monotherapy 3nd-line PD-L1 +ve (≥1%) gastric/GEJ adenocarcinoma Not converted
23 May 2017 Monotherapy 2nd-line MSI-H or mismatch repair-deficient tumours Not converted
18 May 2017 Monotherapy 2nd-line or chemo-ineligible (1st-line) urothelial carcinoma Not converted
10 May 2017 Chemo combo 1st-line Alk & EGFR -ve non-squam NSCLC Converted to full approval
14 Mar 2017 Monotherapy 4th-line classical Hodgkin lymphoma Converted to full approval
5 Aug 2016 Monotherapy 2nd-line head & neck cancer regardless of PD-L1 status Converted to full approval
2 Oct 2015 Monotherapy 2nd-line PD-L1 +ve (≥50%) NSCLC Converted to full approval
4 Sep 2014 Monotherapy 2nd-line melanoma Converted to full approval
Source: Evaluate Vantage & product labels.

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