
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1 May 2017 | Monotherapy | 2nd-line urothelial carcinoma | Withdrawn |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. |