Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients.
As part of the Drugs to Watch™ program, Clarivate experts use proprietary data sources, landscape and event monitoring and deep market knowledge to identify key drug developments expected to have a significant impact on patients and markets.
In this oncology edition, we explore key results highlighted at the European Society for Medical Oncology (ESMO) Congress 2022 and provide analysis on how they will reshape the drug market landscape, along with analysis of some noteworthy oncology drugs in the rapidly expanding Mainland China marketplace.
Read on to for insights from our analysts on:
- Global highlights from ESMO 2022
- Key ESMO 2022 highlights from Mainland China
Seven global highlights from ESMO 2022
1. TRODELVY® demonstrated improved OS in heavily pretreated HR+/HER2-negative metastatic breast cancer
Positive outcomes in a key patient segment could broaden TRODELVY’s uptake in metastatic breast cancer.
A high unmet need exists for patients with heavily pretreated HR+/HER2-negative metastatic breast cancer. The phase 3 TROPICS-02 trial is examining TRODELVY, a TROP2-targeting ADC from Gilead Sciences Inc., in HR+/HER2-negative metastatic breast cancer patients who received prior endocrine-based therapies and a minimum of two chemotherapies. Although the trial met its primary endpoint of PFS, a significant overall survival (OS) benefit was not observed for TRODELVY at the first interim analysis. Updated results from the TROPICS-02 study were presented at the ESMO 2022 congress.
Key ESMO findings
At the second interim analysis for survival, TRODELVY significantly improved OS over physician’s choice of chemotherapy (14.4 vs. 11.2 months; HR, 0.79, P = 0.020), reducing the risk of death by 21%. Furthermore, a subgroup post-hoc analysis showed significant progression-free survival (PFS) benefits for TRODELVY in both the HER2-low (HR 0.58) and HER2-IHC0 (HR 0.72) subpopulations.The readout in the HER2-low group was particularly striking, with a median PFS gain of 2.2 months over control. Taken together, the results show that TRODELVY elicits clinically meaningful activity in heavily pretreated HR+ patients regardless of HER2 IHC (ImmunoHistoChemistry) test status.
TRODELVY is already authorized for certain patients with previously treated metastatic triple-negative breast cancer. Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. With its anticipated approval as a later-line treatment, the population eligible for TRODELVY will increase substantially and serve to boost the drug’s commercial potential.
2. PADCEV® and KEYTRUDA® combination makes strides in treatment-naïve and cisplatin-ineligible advanced urothelial carcinoma
Will tumor response data suffice for the combination to get the green light in this patient segment?
Gemcitabine plus carboplatin is a conventional chemotherapy regimen for treatment-naïve, cisplatin-ineligible advanced urothelial carcinoma. Initial analysis of the exploratory cohort A in the phase 1b/2 multicohort EV-103 (KEYNOTE-869) trial showed favorable results for PADCEV in combination with Keytruda over chemotherapy among first-line, cisplatin-ineligible patients (objective response rate or ORR 73%, median OS of 26 months). In July 2022, positive results from cohort K were announced, with a 65% ORR per blinded independent central review (BICR) in treatment-naïve, cisplatin-ineligible advanced or metastatic urothelial carcinoma patients treated with the PADCEV plus KEYTRUDA combination.
Key ESMO findings
Additional, noncomparative data from cohort K, randomized 1:1 to PADCEV alone or in combination with KEYTRUDA, were presented at the ESMO 2022 Congress. PADCEV plus KEYTRUDA led to 11% complete response and 54% partial response. The ORR for PADCEV alone was 45% (including 4% complete response and 41% partial response). After a median follow-up of 14.8 months, the median PFS and duration of response had not yet been reached for the combination therapy; median OS was estimated at 22.3 months. In the monotherapy arm, the median duration of response was 13.2 months, the median PFS was 8.0 months, and the median OS was 21.7 months.
These data suggest great potential for PADCEV in combination with KEYTRUDA as a first-line option for cisplatin-ineligible, advanced urothelial carcinoma. The companies have hinted at potentially seeking an accelerated approval based on these results. In that scenario, the phase 3 EV-302 (KEYNOTE-A39) trial would serve as a confirmatory trial for this combination in previously untreated patients. If approved, we anticipate healthy uptake of PADCEV plus KEYTRUDA given the need for new treatment options in this patient segment.
3. Fruquintinib meets the primary endpoint of overall survival in heavily pretreated refractory metastatic colorectal cancer
Fruquintinib will face fierce competition should it be approved in the third- and later-line setting.
Hutchmed´s fruquintinib is a highly selective and potent oral inhibitor of VEGFR1-3. It is approved in China for third- and later-line metastatic colorectal cancer based on the phase 3 FRESCO study, which demonstrated significant improvements in PFS and OS over placebo. The global FRESCO-2 trial evaluated fruquintinib in heavily pretreated metastatic colorectal cancer and has been granted FDA fast-track status for this indication.
Key ESMO findings
FRESCO-2 demonstrated a statistically significant OS benefit for fruquintinib plus best supportive care (BSC) compared with placebo plus BSC (median OS 7.4 vs. 4.8 months; HR: 0.66, P<0.001) in a broad patient population that had received a median of five prior lines of therapy (chemotherapy, anti-VEGF or EGFR therapy, immune checkpoint inhibitors, BRAF inhibitor and progressed on or intolerant of LONSURF® and/or STIVARGA®). Median PFS (secondary endpoint) also significantly improved with fruquintinib versus control (3.7 vs. 1.8 months; HR: 0.321, P<0.001). Fruquintinib was well-tolerated, with a safety profile consistent with that previously reported in other studies.
The FRESCO-2 trial results are remarkable given the challenge to demonstrate clinically meaningful outcomes in heavily pretreated patients. Based on the FRESCO and FRESCO-2 studies, Hutchmed is aiming for an approval in the third- and later-line settings across the major markets, positioning fruquintinib in an already crowded market. If approved, fruquintinib will compete fiercely with existing therapies but also with promising emerging therapies poised to enter the market, notably fixed-dose combinations of anti-LAG-3 and anti-PD-1 inhibitors (Opdualag™; favezelimab and KEYTRUDA).
4. The KRAS inhibitors LUMAKRAS®/LUMYKRAS® and adagrasib demonstrate promising activity in KRAS G12C-mutated metastatic colorectal cancer
Combining KRAS inhibitors and anti-EGFR therapies could offer new treatment options in this segment of high unmet need.
Half of metastatic colorectal cancers harbor a RAS mutation; KRAS G12C mutations occur in 3-4% of cases and are associated with poor prognosis. Amgen is evaluating LUMAKRAS/LUMYKRASin the phase 1/2 CodeBreak 101 study in heavily pretreated KRAS G12C-mutated advanced solid tumors, including colorectal cancer. Mirati Therapeutics is investigating their KRAS inhibitor, adagrasib, in the phase 1/2 KRYSTAL-1 trial in the same biomarker-defined segment.
Key ESMO findings
In cohort A (part 2) of the phase 1/2 CodeBreak 101 trial, LUMAKRAS/LUMYKRAS in combination with Vectibix® (anti-EGFR antibody) demonstrated an ORR of 30% (higher than LUMAKRAS/LUMYKRAS monotherapy; 9.7%), disease control rate (DCR) of 93% and consistent safety and tolerability profile as previously reported in heavily pretreated KRAS G12C-mutated metastatic colorectal cancer.Separately, updated data from the potentially registrational-enabling phase 1/2 KRYSTAL-1 trial showed encouraging clinical activity of adagrasib in combination with Erbitux (anti-EGFR antibody) with an ORR of 46%, DCR of 100% and median PFS of 6.9 months in a similar patient population.
KRAS inhibitors in combination with anti-EGFR therapies show promising activity in heavily pretreated KRAS G12C-mutated metastatic colorectal cancer and could offer a vital treatment option for this patient population. The question of which KRAS inhibitor is most effective remains elusive, although being first to market in addition to strong efficacy and safety data could differentiate the more competitive agent.
5. ERLEADA® plus ADT prolongs PSA PFS in high-risk biochemically recurrent prostate cancer
The combination could benefit select high-risk prostate cancer patients with short PSA doubling time.
Janssen’s ERLEADA is approved for certain patients with nonmetastatic castrate-resistant and metastatic hormone-sensitive prostate cancer. Numerous phase 3 trials are under way in additional patient populations including the PRESTO trial, which is evaluating ERLEADA in combination with Androgen Deprivation Therapy (ADT, e.g. FIRMAGON® or leuprolide) with or without abiraterone in high-risk biochemically recurrent prostate cancer (with prostate-specific antigen or PSA doubling time ≤ 9 months). The biochemically recurrent treatment setting is heterogenous with no clear consensus on timing of hormonal therapy and duration of therapy among physicians.
Key ESMO findings
The phase 3 PRESTO trial showed that ERLEADA plus ADT improves median PSA progression-free survival versus ADT alone (24.9 months vs. 20.3 months; HR 0.52; P= 0.00047). ERLEADA plus abiraterone and ADT also demonstrated significant additional PSA PFS benefit versus ADT alone (26.0 months vs. 20.0 months; HR 0.48; P = 0.00008). ERLEADA plus ADT had similar safety outcomes as ADT alone, but the addition of abiraterone led to an increase in the incidence of serious adverse events.
Positioning ERLEADA in biochemically recurrent prostate cancer is clinically compelling because the treatment landscape has seen little change in decades. The PRESTO results are promising for select patients with short PSA doubling time. If approved, ERLEADA is likely to compete with Pfizer’s XTANDI®, which is also poised to enter this setting and may benefit from greater physician familiarity.
6. Roche’s TECENTRIQ®, in combination with chemotherapy and bevacizumab, fails to meet primary endpoints in recurrent platinum-sensitive ovarian cancer
The failure casts further doubt upon the role of immunotherapy in ovarian cancer.
In contrast to many oncology indications, the progress of immune checkpoint inhibitors in ovarian cancer has been disappointing so far, with three phase 3 trials failing to meet their primary endpoints: the Javelin 100 and Javelin 200 trials investigating Bavencio plus chemotherapy in the newly diagnosed and platinum-resistant or -refractory settings, respectively, and the IMagyn050 trial evaluating TECENTRIQ plus chemotherapy and bevacizumab in the newly diagnosed setting. At ESMO 2022, the phase 3 ATALANTE trial investigating TECENTRIQ plus chemotherapy and bevacizumab in the platinum-sensitive setting was also announced to have failed to meet its primary endpoints.
Key ESMO findings
Results from the ATALANTE trial showed that TECENTRIQ plus platinum-based chemotherapy and bevacizumab failed to significantly improve PFS in recurrent platinum-sensitive patients versus platinum-based chemotherapy plus bevacizumab in both the intent-to-treat (13.5 vs. 11.2 months; HR 0.83, P = 0.041) and PD-L1-positive (15.2 vs. 13.1 months; HR 0.86, P = 0.30) populations. Median OS in the TECENTRIQ versus control arms was 35.4 vs. 30.6 months (HR 0.81).
Despite the disappointing results reported to date, immune checkpoint inhibitors still represent the largest class of emerging therapies in phase 3 development for ovarian cancer. The failure of the ATALANTE trial casts further doubts on the role of immunotherapy in ovarian cancer. Nevertheless, the OS data reported from this study, while immature, are encouraging, and longer-term follow-up is warranted.
Ongoing trials are also exploring the combination of immune checkpoint inhibitors plus PARP inhibitors, which may produce synergistic effects; preliminary results from these trials are expected next year. If these trials also produce negative results, the use of immunotherapy in ovarian cancer is unlikely to be a strategy that is pursued much further.
7. Roche’s TECENTRIQ® and BMS’s OPDIVO® with or without YERVOY® stumble in adjuvant renal cell carcinoma
These setbacks will cement KEYTRUDA’s position as the market leader in this lucrative setting.
The adjuvant treatment setting represents a highly lucrative space in the renal cell carcinoma market. SUTENT® was the first adjuvant therapy to be approved in the United States. KEYTRUDA subsequently gained approval in both the United States and Europe, as the first adjuvant immune checkpoint inhibitor for patients at high-risk of recurrence following nephrectomy. Several other immune checkpoint inhibitors are being investigated in this setting.
Key ESMO findings
Results from three negative phase 3 trials in adjuvant renal cell carcinoma at high-risk of recurrence were presented. OPDIVO plus YERVOY (CheckMate 914 trial) and TECENTRIQ (IMmotion010 trial) failed to show statistically significant improvement in disease-free survival against placebo. The PROSPER trial evaluating perioperative OPDIVO compared with surgery alone and observation was stopped early due to futility; recurrence-free survival was similar in both arms.
The disappointing results of these key clinical trials are a major setback for OPDIVO (alone or with YERVOY) and TECENTRIQ and will serve to strengthen KEYTRUDA’s position in the adjuvant renal cell carcinoma market. Of note, an ongoing academic sponsored trial is evaluating adjuvant IMFINZI® with or without tremelimumab (phase 3 RAMPART) and could shed further light on the potential of immunotherapy in this patient segment.
Three key ESMO 2022 highlights from Mainland China
1. Pyrotinib plus trastuzumab and chemotherapy may become a new treatment option for untreated HER2-positive metastatic breast cancer
Will these data suffice to compete with Roche’s PERJETA® as the first-line treatment of choice?
In April 2019, Jiangsu HengRui initiated the phase 3 PHILA trial to evaluate the clinical benefit of dual HER2 inhibition with a combination of pyrotinib (Airuin), a tyrosine kinase receptor inhibitor, plus trastuzumab and docetaxel as first-line treatment for HER2-positive metastatic breast cancer.
Key ESMO findings
The company presented encouraging findings from the PHILA trial in 590 patients with previously untreated HER2-positive metastatic breast cancer. Pyrotinib in combination with trastuzumab and docetaxel demonstrated a significant 13.9-month improvement in median PFS over trastuzumab plus docetaxel (HR 0.41, P< 0.0001). Of note, serious treatment-related adverse events were much higher in the pyrotinib arm (25%) versus control (6%).
Previously untreated HER2-positive metastatic breast cancer patients typically receive pertuzumab (PERJETA) plus trastuzumab and docetaxel. If the final results from PHILA are consistent with preliminary findings, we expect that pyrotinib (plus trastuzumab and chemotherapy) will get approval as frontline treatment and experience solid uptake. Nevertheless, the anticipated entry of pertuzumab biosimilars in 2025 and the reimbursement status for both brands on NRDL in this patient segment is likely to influence first-line uptake of pyrotinib in Mainland China.
2. Dalpiciclib in combination with an aromatase inhibitor proves effective as frontline therapy for HR+/HER2-negative metastatic breast cancer
If approved, dalpiciclib will be the third CDK4/6 inhibitor to enter this patient segment and intensify intra-class competition.
CDK4/6 inhibitors are emerging as the standard of care for the management of previously untreated HR+/HER2-negative metastatic breast cancer in Mainland China, including Pfizer’s IBRANCE® and Eli Lilly’s Verzenio®.
Key ESMO findings
Jiangsu Hengrui Pharmaceuticals presented positive findings from the ongoing phase 3 DAWNA-2 study. Dalpiciclib (AiRuiKang®) in combination with letrozole or anastrozole demonstrated a significant median PFS benefit of over 12 months compared with letrozole or anastrozole alone in previously untreated HR+/HER2-negative metastatic breast cancer (HR 0.51, P <0.0001).
In Mainland China, dalpiciclib is the only CDK4/6 inhibitor approved for HR+/HER2-negative metastatic breast cancer patients with disease progression after endocrine therapy. We expect that the positive DAWNA-2 results will serve to expand its label to include first-line treatment. Dalpiciclib may have an edge over its direct competitors IBRANCE and Verzenia because their use is restricted to previously untreated patients only. Of note, we anticipate dalpiciclib will be listed on the NRDL in 2022, which will further boost its market uptake.
3. Camrelizumab plus apatinib show promise as a first-line treatment in advanced hepatocellular carcinoma
Positive phase 3 data could help the combination emerge as a new treatment option in this setting.
Combination therapies are rapidly emerging as new standards of care for advanced hepatocellular carcinoma in Mainland China. Despite the approval of atezolizumab plus bevacizumab and sintilimab plus bevacizumab, there remains a high unmet need for newer, more effective, and affordable treatment options in this treatment setting.
Key ESMO findings
Jiangsu Hengrui presented positive findings from an international phase 3 study in 543 previously untreated unresectable patients. Camrelizumab (AiRuiKa™) plus apatinib demonstrated a statistically and clinically significant improvement in median OS over sorafenib (i.e. NEXAVAR®, 22.1 vs. 15.2 months). The combination also showed higher ORR over sorafenib (25% vs. 6%) and longer median PFS (5.6 vs. 3.7 months). Of note, a higher rate of discontinuation due to treatment-related adverse events was noted in the combination arm (24%; any treatment) than with sorafenib (5%).
Jiangsu Hengrui’s AiRuiKa is already approved for second-line treatment of unresectable hepatocellular carcinoma. We believe positive findings from this study will fuel its uptake in the first line as well, given that it seemingly outperforms most current and emerging therapies in development, including atezolizumab plus bevacizumab (OS of 19.1 months), sintilimab plus bevacizumab (OS not reached), durvalumab plus tremelimumab (OS of 16.4 months), and pembrolizumab plus lenvatinib (OS 21.2 months). Camrelizumab plus apatinib has a promising clinical profile and is likely to be widely accessible in Mainland China (both drugs are developed domestically and on the NRDL) but it will likely face competition from emerging monotherapies with more favorable safety and tolerability, including AstraZeneca’s durvalumab (IMFINZI®) and BeiGene’s tislelizumab.
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Contributors to this report included: Ananya Sadhu, Senior Analyst, China In-Depth; Elliott Puttock, Analyst, Oncology; Khurram Nawaz, Senior Director, Oncology; Kiran Bountra, Senior Analyst, Oncology; Laura Ramos García, Analyst, Oncology; Laura Vinuesa, Senior Analyst, Oncology; Leena Kathuria, Senior Manager, Oncology; Liseth Parra, Analyst, Oncology; Rachel Webster, Head of Oncology and Biosimilars; Ruchita Kumar, Senior Manager, China In-Depth; Samantha Wang, Analyst, China In-Depth; Sarvendu Kumar, Manager, Oncology; Saurabh Virdi, Principal Analyst, Oncology; and Tiffany Chan, Analyst, Oncology